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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Melphalan

Criteria

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