Penile Cancer

Condition: Urologic Neoplasms, Urogenital Neoplasms, Male Urogenital Diseases, Penile Cancer, Penile Squamous Cell Carcinoma, Locally Advanced Penile Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06353906

Sponsor: The Netherlands Cancer Institute

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

• 1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 2. Histologically confirmed diagnosis of squamous cell carcinoma of the penis. 3. Patients have one of the following disease stages:
• cTxN2-3 or
• cTxN1 in case of central nodal necrosis and/or an irregular nodal border, or node >3cm, or
• Inguinal or pelvic lymph node recurrence that is potentially resectable. Any of the disease stages above, in combination with oligometastatic disease with a maximum of 2 distant metastases is allowed, as long as these metastases can be treated by resection or radiotherapy. This should be established in the multidisciplinary tumor board before enrolment. 4. Archival tumor tissue sample or newly obtained [core, incisional or excisional] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. 5. A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period. 6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 14 days prior to the first dose of study intervention. 7. Have adequate organ function defined as: absolute neutrophil count (ANC) ≥1.5 10e9 /L, platelets ≥100 10e9/L; hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L; creatinine ≤1.5 × ULN OR GFR>30 ml/min as per Cockcroft-Gault formula in patients with creatinine levels > 1.5x institutional ULN; total bilirubin 1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN; International normalized ratio (INR), prothrombin time (PT) OR activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. Specimens must be collected within 14 days prior to the start of study intervention.

Exclusion Criteria:

1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
2. Has received prior systemic anti-cancer therapy including investigational agents, or an investigational device, within 4 weeks prior to registration.
3. Has received prior radiotherapy within 4 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
4. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
6. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Exceptions: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Patients with low-risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤ 6, and PSA ≤ 10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible.
7. Has known active or treated CNS metastases and/or carcinomatous meningitis.
8. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
9. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid). Patients with vitiligo, psoriasis or other mild skin disease can still be included.
10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
11. Has an active infection requiring systemic therapy.
12. Has a known history of Human Immunodeficiency Virus (HIV) infection.
13. Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and/or Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Hepatitis B and C screening tests are not required unless a patient has a known history of HBV or HCV infection. Participants must have completed curative anti-viral therapy at least 6 months prior to randomization.
14. Has not adequately recovered from major surgery or has ongoing surgical complications.
15. Major pelvic surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for the disease under study.
16. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
18. Is expecting to father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
19. Has had an allogenic tissue/solid organ transplant

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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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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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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.

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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.

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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

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

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

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

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

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

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

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

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

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

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

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

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

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

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