Evaluation of Lymphadenectomy and Chemotherapy TIP on Inguinal Lymph Nodes in Squamous Cell Carcinoma of the Penis

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 nopalpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / orGrade 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 limitof 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 thepatient and one for the partner) for the duration of the study and for 6 monthsafter the last dose of treatment,

16. Patients able to comply with the protocol requirements (scheduled visits, treatmentplan, 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 thancutaneous 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 experimentaltreatment 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 thatis incompatible with the patient's participation in the trial according toinvestigator,

14. immunocompromised patients including with known seropositivity (HIV),

15. Patients with mental impairment which prevents the understanding of the protocol orhaving a psychological state, family, sociological or geographical conditions thatwould not allow compliance with the protocol and the planned follow-up or anycondition which, according to the investigator, would prevent participation patienttested. These conditions should be assessed before inclusion of patients.