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.
|Gynaecologic or Digestive Pelvic Cancer||Drug: Isolated pelvis perfusion Radiation: radiotherapy Procedure: Surgery||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- Survival rate [ Time Frame: From randomization to death ]
|Study Start Date:||February 2009|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Isolated pelvis perfusion
Drug: Isolated pelvis perfusion
injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg
Active Comparator: Control
chemotherapy and/or radiotherapy and/or surgeryProcedure: Surgery
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949039
|Institut Gustave Roussy|
|Villejuif, France, 94800|