Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer

Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery).

Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer.

The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated pelvic perfusion.

Inclusion Criteria:

• Histologically proved locally advanced gynaecologic or digestive tumours (epidermoid carcinomas, adenocarcinomas, neuroendocrine tumours, sarcomas or melanomas), (cervix, vagina, rectal, anal).
• Locally recurrent tumours for which surgical treatment will be mutilating or marginal (R1 or R2) and/or for cervix cancer, primary tumours non accessible for standard treatment (radiotherapy- chemotherapy - brachytherapy and surgery).
• Surgically resectable tumour (R0 type) but for which patient does not agree with surgery.
• Patients aged over 18 and under 76 ans
• Performance OMS Index ≤ 2
• Normal biologic parameters
• Good general and cardiac state (ASA I or II and NYHA I or II)

Exclusion Criteria:

• Surgically resectable tumour (RO) or peritoneal tumour extension or distant metastasis.
• Cardiac or vascular pathology
• Pulmonary disease
• Uncontrolled Sepsis disease
• Pregnancy