IFOSFAMIDE for Squamous cell carcinoma of the penis

Inclusion criteria

• {"criterion_text":"- Penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy"}
• {"criterion_text":"- Normal calcemia and kaliemia"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Creatinine clearance ≥60 mL/min (MDRD method),"}
• {"criterion_text":"- Left ventricular ejection fraction (LVEF) >50%"}
• {"criterion_text":"- Patients having received, read the information note and signed consent"}
• {"criterion_text":"- 15.\tReproductive 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,"}
• {"criterion_text":"- Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),"}
• {"criterion_text":"- Patients undergoing a social security scheme"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Metastatic lymph node involvement"}
• {"criterion_text":"- Patients M0 or Mx"}
• {"criterion_text":"- Age ≥18 ans"}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) 0-1"}
• {"criterion_text":"- Leucocytes ≥1.5 g/L"}
• {"criterion_text":"- Hemoglobin ≥9 g/dL"}
• {"criterion_text":"- Platelets ≥100 000/mm³"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Survival without locoregional lymph node recurrence [ Time Frame: 24 months ] checked by inguinal ultrasound","definition_or_measurement_approach":"Time Frame: 24 months; checked by inguinal ultrasound (as stated: \"checked by inguinal ultrasound\")"}

France

Earliest CTIS Part Ii Submission Date

10-04-2024

Latest Decision Or Authorization Date

14-05-2024

Processing Time Days

34

Number Of Sites

20

Number Of Participants

37

Primary sponsor

Full Name

Unicancer

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Ligue contre le cancer","duties_or_roles":"Monetary support","organisation_type":""}