Phase III trial comparing pelvic isolated perfusion (PIP) with TNF-α 0.3 mg and melphalan 1.5 mg/kg versus standard treatment in locally advanced pelvic tumors of gynecological or digestive origin - PIP 2

INTERVENTION: Product Name: melphalan Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: melphalan Product Name: TNF Alpha Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: TNF alpha CONDITION: Locally advanced pelvic tumor of gynecological or digestive origin; MedDRA version: 9.1 Level: LLT Classification code 10048936 Term: Pelvic tumor PRIMARY OUTCOME: Main Objective: 25% absolute increase in 1-year survival rate with isolated pelvic infusion. Primary end point(s): 1-year overall survival Secondary Objective: 1-year local progression-free survival; - Response to treatment after Isolated Pelvic Infusion; - Patient quality of life; - Local and systemic toxicities; INCLUSION CRITERIA: - Histologically proven tumors (squamous cell carcinomas, adenocarcinomas, neuroendocrine tumors, sarcomas, or melanomas) of gynecological (cervix or vagina) or digestive (rectum or anal canal) origin, with local progression. - Tumors with local recurrence for which surgical excision would be mutilating or marginal (R1 or R2) and/or, for cervical cancers: primary tumors not amenable to standard treatment (radiotherapy, chemotherapy, and surgery). - Surgically resectable tumor (type R0) but for which surgery is refused by the patient. - Patients aged over 18 and no more than 75 years. - WHO performance status = 2 (Appendix 1). - Hematological function: Hemoglobin > 9 g/dl as needed after transfusion; leukocytes > 2000 /mm3; platelets > 100,000/mm3 - Hepatic function: assessment (SGOT, SGPT, alkaline phosphatases and bilirubinemia) < 1.5 upper limit of normal.