Penile Cancer

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PERICLES (PEnile Cancer Radio- and Immunotherapy CLinical Exploration Study)-a Phase 2 Study of Atezolizumab With or Without Radiotherapy in Penile Cancer


Condition: Penile Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03686332

Sponsor: The Netherlands Cancer Institute

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Written informed consent, prior to performing any protocol-related procedures, including screening evaluations.
  • Age > 18 years at time of study entry.
  • Advanced histologically documented, squamous cell carcinoma of the penis or distal urethra. Advanced disease is defined as:
  • Distant metastases, OR
  • LRAPC, defined as a large or inoperable primary tumor (T4), palpable nodes >3cm in diameter or fixed nodes, suspicion of extra-nodal extension or pelvic node involvement (N2/N3)
  • Arm A: Locoregional disease (with or without distant metastases), likely to derive benefit from locoregional radiotherapy and not previously treated with radiotherapy.
  • Arm B: Benefit of locoregional radiotherapy unlikely OR previously treated with irradiation.
  • World Health Organisation (WHO) performance status of 0 or 1.
  • Life expectancy of > 12 weeks.
  • Adequate normal organ and marrow function as defined below:
  • Haemoglobin ≥ 5.6/mmol/L
  • White blood cell count (WBC) ≥ 2 x 109/L
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L (>100,000 per mm3)
  • Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome, who will be allowed in consultation with a study physician.
  • AST/ALT ≤ 2.5 x institutional ULN unless liver metastases are present, in which case it must be ≤ 5x ULN.
  • Serum creatinine clearance >30 mL/min by calculation with the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection measurement.

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study (applies to both Roche staff and/or staff at the study site) or previous enrolment in the present study.
  • Participation in another clinical study with an investigational product during the last 4 weeks
  • Any previous treatment with a PD-1 or PD-L1 inhibitor
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of study drug
  • Low potential risk of 3-year cancer-specific death (estimated<5%), including adequately treated non-melanoma skin cancer without evidence of disease, adequately treated carcinoma in situ without evidence of disease, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score ≤ 7 and PSA < 10 ng/mL) undergoing active surveillance.
  • Treatment with the last dose of any systemic anti-cancer therapy ≤ 21 days prior to the first dose of study drug. Local treatment of isolated lesions for palliative intent is acceptable (eg, local surgery or radiotherapy).
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at doses ≤10 mg/day of prednisone, or an equivalent corticosteroid.
  • History of primary immunodeficiency, allogeneic organ transplant or autoimmune disease, including
  • but not limited to
  • myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone will not be excluded from this study. Patients with controlled diabetes mellitus type I on a stable dose of insulin regimen may be eligible for this study.
  • Uncontrolled significant intercurrent illness, including
  • but not limited to - ongoing or active infection (including acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV)), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
  • Known active tuberculosis
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
  • Brain metastases or leptomeningeal disease. Inclusion of patients with brain metastases is allowed if patients have been adequately treated, are not symptomatic and show no signs of progression on brain imaging 28 days after completion of treatment (including surgery, radiotherapy or treatment with systemic corticosteroids).
  • Subjects with uncontrolled seizures.

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Activity and Tolerability of Maintenance Avelumab Immunotherapy After First Line Polychemotherapy Including Platinum in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma


Condition: Penile Cancer, Penile Neoplasms, Penile Squamous Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03774901

Sponsor: Centre Hospitalier Universitaire de Besancon

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Eligibility Criteria:

  • Inclusion:
  • Histologically confirmed unresectable locally advanced or metastatic squamous cell penile carcinoma
  • Patients who have received a minimum of 3 and a maximum of 6 cycles of polychemotherapy including a platinum (cisplatin or carboplatin) administered as 1st line systemic treatment. In the event of pretreatment with cisplatin: a cumulative minimum dose of 210 mg/m2 is required in order to be eligible. In the event of pretreatment with carboplatin: a minimum cumulative dose equivalent to 3 cycles of carboplatin AUC5 is required to be eligible
  • Patients without disease-progression according to the RECIST v1.1 criteria (i.e. in complete or partial response or stable disease at inclusion) after 3 to 6 cycles of 1st line chemotherapy.
  • ECOG (Eastern Cooperative Group) performance status of 0 to 2
  • Adequate organ function: Absolute neutrophil (N) count ≥ 1500/mm3 ou ≥ 1,5.10^9/L Platelets ≥ 100 000 / mm3 Haemoglobin ≥ 9 g/dL Creatinine clearance ≥ 30 mL/min (by the MDRD formula) Total bilirubin ≤ 1.5 x ULN (upper limit of the normal range) AST ≤ 2.5 x ULN and ALT ≤ 2.5 x ULN OR AST and ALT ≤ 5 x ULN if liver abnormalities due to liver metastases AST = aspartate aminotransferase ALT = alanine aminotransferase Exclusion:
  • Patients who have never received chemotherapy with a platinum (cisplatin or carboplatin)
  • Patients who have received more than one previous line of systemic treatment for penile cancer unless in case of more than 12 months delay between the end of prior treatment and the start of platinum containing polychemotherapy required.
  • Patients whose disease has progressed according to RECIST v1.1 criteria after 1st line chemotherapy for penile cancer. The cancer must not be in the progression phase at inclusion
  • Past history of immunotherapy treatment with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or an anti- CTLA-4 antibody (including ipilimumab) or any other antibody or medicinal products specifically targeting anti-cancer immunotherapy
  • Major surgery within 4 weeks or major radiotherapy within 2 weeks prior to starting avelumab. Previous palliative radiotherapy (≤ 10 fractions) for metastatic lesions is permitted, provided that this has been completed at least 48 hours prior to starting avelumab
  • Patients with a past history of known central nervous system metastases, meningeal carcinomatosis or spinal compression
  • Existence of a past history of cancer within 3 years prior to inclusion into the study (excluding cured localised cancer such as non-melanomatous skin cancers, superficial bladder cancers and localised prostate cancer with undetectable PSA)
  • Active autoimmune disease, which may deteriorate following administration of an immunostimulatory agent. Patients suffering from type I diabetes, vitiligo, psoriasis or hypo- or hyperthyroidism not requiring immunosuppressant treatment are eligible
  • Patients with uncontrolled adrenal failure
  • Any of the following events in the 3 months prior to inclusion: myocardial infarction, severe/unstable angina, coronary/periphery artery bypass, symptomatic congestive heart failure, cerebrovascular accident, transient ischaemic attack.
  • Pulmonary embolism or deep vein thrombosis within 3 months prior to inclusion (unless if stable, asymptomatic and treated with a low molecular heparin for at least 10 days prior to starting the avelumab)
  • Active infection requiring systemic treatment
  • Current treatment with an immunosuppressant medicinal product or treatment within 7 days prior to inclusion, EXCEPT: a
  • Intra-nasal, inhaled or local steroids or local steroid injections (such as intra-articular injections) b
  • Systemic corticosteroids at physiological doses of ≤ 10 mg/day of prednisone or equivalent c
  • Steroids as premedication for hypersensitivity reactions (such as CT scan premedication).
  • Diagnosis of human immunodeficiency virus (HIV) infection or disease related to the acquired immunodeficiency syndrome (AIDS). In patients who are seropositive for HIV but have a disease deemed to be controlled on anti-viral therapy from the opinion of the patient's HIV contact doctor: inclusion is still possible if the CD4 count is ≥ 300/mm3
  • Previous organ transplant including stem cell allotransplantation
  • Any screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating active infection
  • Vaccination within 4 weeks prior to first administration of avelumab and throughout the period of the study, except with inactivated vaccines (such as, inactivated influenza vaccines).
  • Men of childbearing age who do not wish or cannot use 2 methods of highly effective contraception (oral contraceptives, contraceptive injections, intra-uterine devices, dual barrier method or contraceptive patches) as described in the protocol throughout the study and for at least 60 days after the last dose of avelumab
  • Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study

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A Phase 2, Multi-centre, Open-label Study of Avelumab (MSB0010718C) in Locally Advanced or Metastatic Penile Cancer Patients Unfit for Platinum-based Chemotherapy or Progressed On or After Platinum-based Chemotherapy


Condition: Penile Cancer, Advanced Cancer, Metastatic Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03391479

Sponsor: University Health Network, Toronto

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the penis
  • Measurable disease per Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
  • Unresectable/metastatic disease that is unfit for platinum-based chemotherapy OR disease that has progressed on or after treatment with platinum-based chemotherapy
  • ≥18 years of age
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Exclusion Criteria:

  • Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
  • Major surgery ≤4 weeks or major radiation therapy ≤2 weeks prior to enrollment
  • Known symptomatic central nervous system (CNS) metastases requiring steroids
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy

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Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC): an Open-label, Single-center, Phase 2, Single-arm Trial (CaboPen)


Condition: Penile Squamous Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03943602

Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: Male

Inclusion Criteria:

  1. Age 18-75
  2. Written informed consent
  3. ECOG (Eastern Cooperative Oncology Group) performance status 0-1
  4. Cytologically or histologically proven diagnosis of PSCC.
  5. Histologically (Tru-cut biopsy) proven diagnosis of loco-regional nodal disease will be required in all cases except for those with clinical contraindications.
  6. Uni- or bidimensionally measurable disease as defined by RECIST v1.1 criteria.
  7. Clinical stage N2-3 and/or M1 (TNM 2002).
  8. Locoregional relapse after prior major surgery/ies (either single or multiple).
  9. No prior systemic therapy except for the administration of VBM (Vinblastine, Bleomycin, Methotrexate) chemotherapy for superficial disease if administered at least 6 months prior to study enrolment.
  10. Adequate organ and marrow function .
  11. Patients must be accessible for treatment and follow up as well as they must be willing and capable to comply with the requirements of the study. Patients registered on this trial must be treated and followed at the study sponsor site.

Exclusion Criteria:

  • 1. History of any one or more of the following cardiovascular conditions within the past 6 months:
  • Cardiac angioplasty or stenting.
  • Myocardial infarction.
  • Unstable angina.
  • Coronary artery by-pass graft surgery.
  • Symptomatic peripheral vascular disease.
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
  • Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted during the study but should be used with caution
  • please refer to the study drug IB).
  • Screening ECG with a QTc>450 msec, congenital long QT syndrome, history of sustained ventricular tachycardia, history of ventricular fibrillation or torsade de pointes, bradycardia defined as heart rate < 50 bpm (patients with a pacemaker and heart rate > 50 bpm are eligible).
  • Uncontrolled hypertension. 2. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months ior to first dose of study drug. 3. History of HIV infection or active chronic hepatitis B or C. 4. Active clinically serious infections (> grade 2 NCI-CTC version 5.0). 5. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics). 6. Patients undergoing renal dialysis 7. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT treated basal cell carcinoma or any cancer curatively treated > 5 years prior to study entry. 8. History of clinically-significant gastrointestinal bleeding, inflammatory bowel disease, and other GI disorders associated with high risk of perforation or fistula formation or any other condition. 9. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 10. Major surgery within 12 weeks before the first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment. Minor surgery (including uncomplicated tooth extractions) within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible. 11. History of allogenic organ solid transplantation. 12. Fertile males not willing to use a highly effective method of contraception or whose female partner is not using a highly effective contraception protection. 13. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. 14. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study. 15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug. 16. Hemoptysis >=2.5 ml red blood within 3 months before treatment, signs indicative of pulmonary hemorrhage, cavitating pulmonary lesion, tumor invading major blood vessels and/or GI tract, endotracheal or endobronchial tumors History of clinically-significant gastrointestinal bleeding, inflammatory bowel disease, or any other condition among those listed in the full protocol. 17. Patients unable to swallow oral medications. 18. Concomitant anticoagulation with oral anticoagulants or platelet inhibitors. 19. History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.

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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP


Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
  3. Metastatic lymph node involvement,
  4. Patients M0 or Mx,
  5. Age ≥18 ans,
  6. Eastern Cooperative Oncology Group (ECOG) 0-1,
  7. Leucocytes ≥1.5 g/L,
  8. Hemoglobin ≥9 g/dL,
  9. Platelets ≥100 000/mm³,
  10. Normal calcemia and kaliemia,
  11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
  12. Creatinine clearance ≥60 mL/min (MDRD method),
  13. Left ventricular ejection fraction (LVEF) >50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3),
  2. Iliac lymph nodes (cN3),
  3. Patients pN3,
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their liberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov


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