NCT00949039

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynaecologic or Digestive Pelvic Cancer

Interventions

Type	Name	Description
DRUG	Isolated pelvis perfusion	injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg
RADIATION	radiotherapy	chemotherapy and/or radiotherapy and/or surgery
PROCEDURE	Surgery

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2009-07-30
• Last updated: 2015-03-12

Locations

1 site across 1 country: France