- ICH GCP
- US Clinical Trials Registry
- Clinical 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
March 11, 2015 updated by: Gustave Roussy, Cancer Campus, Grand Paris
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Villejuif, France, 94800
- Institut Gustave Roussy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- Surgically resectable tumour (RO) or peritoneal tumour extension or distant metastasis.
- Cardiac or vascular pathology
- Pulmonary disease
- Uncontrolled Sepsis disease
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemotherapy
Isolated pelvis perfusion
|
injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg
|
Active Comparator: Control
Standard treatment
|
chemotherapy and/or radiotherapy and/or surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival rate
Time Frame: From randomization to death
|
From randomization to death
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
July 7, 2009
First Submitted That Met QC Criteria
July 29, 2009
First Posted (Estimate)
July 30, 2009
Study Record Updates
Last Update Posted (Estimate)
March 12, 2015
Last Update Submitted That Met QC Criteria
March 11, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIP2
- CSET 1443
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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