Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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 Summary:
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Current Primary Outcome: Survival rate [ Time Frame: From randomization to death ]

Original Primary Outcome: survival

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Gustave Roussy, Cancer Campus, Grand Paris

Dates:
Date Received: July 7, 2009
Date Started: February 2009
Date Completion:
Last Updated: March 11, 2015
Last Verified: March 2015