drugset
drugset / Trial / 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

NCT00949039 ↗

Phase 3 Completed 101 enrolled Gustave Roussy, Cancer Campus, Grand Paris
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-02
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan Small molecule 1.5 mg/kg Other
Subject TNF-α Unknown 0.3 mg Other

Indications

No indication recorded.