Penile Cancer

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.

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

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