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
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|ClinicalTrials.gov Identifier: NCT00949039|
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : March 12, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Gynaecologic or Digestive Pelvic Cancer||Drug: Isolated pelvis perfusion Radiation: radiotherapy Procedure: Surgery||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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 surgery
- Survival rate [ Time Frame: From randomization to death ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949039
|Institut Gustave Roussy|
|Villejuif, France, 94800|