Status:
COMPLETED
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
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Gynaecologic or Digestive Pelvic Cancer
Eligibility:
All Genders
18-76 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Histologically proved locally advanced gynaecologic or digestive tumours (epidermoid carcinomas, adenocarcinomas, neuroendocrine tumours, sarcomas or melanomas), (cervix, vagina, rectal, anal).
- Locally recurrent tumours for which surgical treatment will be mutilating or marginal (R1 or R2) and/or for cervix cancer, primary tumours non accessible for standard treatment (radiotherapy- chemotherapy - brachytherapy and surgery).
- Surgically resectable tumour (R0 type) but for which patient does not agree with surgery.
- Patients aged over 18 and under 76 ans
- Performance OMS Index ≤ 2
- Normal biologic parameters
- Good general and cardiac state (ASA I or II and NYHA I or II)
Exclusion
- Surgically resectable tumour (RO) or peritoneal tumour extension or distant metastasis.
- Cardiac or vascular pathology
- Pulmonary disease
- Uncontrolled Sepsis disease
- Pregnancy
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00949039
Start Date
February 1 2009
End Date
March 1 2014
Last Update
March 12 2015
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94800