Evaluation of Lymphadenectomy and Chemotherapy TIP (paclitaxel, ifosfamide and cisplatin) on Inguinal Lymph Nodes in Squamous Cell Carcinoma of the Penis

Phase 1

Recruiting

• Conditions: Therapeutic area: Diseases [C] - Neoplasms [C04]; Penis carcinoma; MedDRA version: 20.0Level: LLTClassification code: 10062064Term: Penis carcinoma Class: 10029104

• Registration Number: CTIS2024-512827-36-00
• Lead Sponsor: nicancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

Penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy, Normal calcemia and kaliemia, 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, Creatinine clearance =60 mL/min (MDRD method),, Left ventricular ejection fraction (LVEF) >50%, 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,, Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),, Patients undergoing a social security scheme, Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Patients with capsular involvement if inguinal lymph nodes are affected exclusively Or If no palpated lymph nodes (cN0), patients with nodes involvement risk =pT1b and / or Grade 2, Metastatic lymph node involvement, Patients M0 or Mx, Age =18 ans, Eastern Cooperative Oncology Group (ECOG) 0-1, Leucocytes =1.5 g/L, Hemoglobin =9 g/dL, Platelets =100 000/mm³

Exclusion Criteria

Fixed inguinal lymph nodes, Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial, Patients deprived of their liberty or under court protection including guardianship, 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, Immunocompromised patients including with known seropositivity (HIV),, 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, Iliac lymph nodes, Prior chemotherapy for squamous cell carcinoma of the penis, Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,, Patients treated with phenytoin, Patients with hearing loss >Grade 1 (CTCAE V4.03),, Patients with cardiopulmonary disease-indicating against overhydration, History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell, Patient received a live attenuated vaccine within 30 days prior to inclusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified