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

Phase 3

Completed

• Conditions: Gynaecologic or Digestive Pelvic Cancer
• Interventions: Drug: Isolated pelvis perfusion; Radiation: radiotherapy; Procedure: Surgery

• Registration Number: NCT00949039
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Surgery	Standard treatment
Chemotherapy	Isolated pelvis perfusion	Isolated pelvis perfusion
Control	radiotherapy	Standard treatment

Primary Outcome Measures

Name	Time	Method
Survival rate	From randomization to death

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, France