CISPLATIN for Anal squamous cell carcinoma (locally advanced)

Inclusion criteria

• {"criterion_text":"- Anal Squamous cell carcinoma histologically proven"}
• {"criterion_text":"- Locally advanced tumors without metastases (Stage T3 or T4 / Stage N1 (a, b or c) - any T (T1 to T4) )"}
• {"criterion_text":"- Age ≥18 and ≤ 75 or > 75 in case of favourable oncodage G8 score or oncogeriatric assessment"}
• {"criterion_text":"- Measurable tumor on MRI"}
• {"criterion_text":"- Able to receive chemotherapy and radiotherapy"}
• {"criterion_text":"- No major comorbidity that may preclude the delivery of treatment"}
• {"criterion_text":"- WHO performance status < 2"}

Exclusion criteria

• {"criterion_text":"- Presence of metastases"}
• {"criterion_text":"- Stage T1N0 or T2N0"}
• {"criterion_text":"- History of pelvic radiotherapy"}
• {"criterion_text":"- Complete or partial Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)"}
• {"criterion_text":"- Positive HIV serology with CD4 < 400 / mm3"}
• {"criterion_text":"- Presence of neuropathy > grade 2"}
• {"criterion_text":"- Concomitant treatment with CYP3A4 inhibitors or inducers"}

Primary endpoints

• {"endpoint_text":"- Disease-related event free survival (DFS) will be defined as the time between the date of randomization and the date of the first event (residual tumor at 6 months requiring an APR, progression, recurrence (local or metastatic) or death) or date of last news if the patient is alive without any event.","definition_or_measurement_approach":"Time from randomization to first event (residual tumor at 6 months requiring APR, progression, recurrence local or metastatic, or death); censored at date of last contact if no event."}

Secondary endpoints

• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Colostomy-free survival (CFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- toxicities and grades according to International Common Terminology Criteria for Adverse Events (CTCAE) version 4.0","definition_or_measurement_approach":"Toxicities graded per CTCAE v4.0"}
• {"endpoint_text":"- Response rate will be evaluated by mRECIST criteria 1.1 and clinical examination","definition_or_measurement_approach":"Response assessed using mRECIST 1.1 and clinical exam"}
• {"endpoint_text":"- Quality of life scores","definition_or_measurement_approach":"QoL instruments listed (EORTC QLQ-C30, EORTC QLQ-ANL27, Jorge & Wexner Score, EORTC SHQ-22) per secondary objectives"}
• {"endpoint_text":"- Pelvic reccurence rate at 2 years","definition_or_measurement_approach":""}
• {"endpoint_text":"- Metastatic reccurence rate at 2 years","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

10-11-2023

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

805

Number Of Participants

310

Primary sponsor

Full Name

Fondation Franc.Cancerologie Digestive

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France