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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2009 by Institut Gustave Roussy.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Institut Gustave Roussy

ClinicalTrials.gov Identifier:

NCT00949039

First received: July 7, 2009

Last updated: August 21, 2009

Last verified: August 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	July 7, 2009
Last Updated Date	August 21, 2009
Start Date ^ICMJE	February 2009
Estimated Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 29, 2009)	survival
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00949039 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	Not Provided
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 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Gynaecologic or Digestive Pelvic Cancer
Intervention ^ICMJE	Drug: Isolated pelvis perfusion injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg Other: standard treatment chemotherapy and/or radiotherapy and/or surgery
Study Arm (s)	Experimental: Chemotherapy Isolated pelvis perfusion Intervention: Drug: Isolated pelvis perfusion Active Comparator: Control Standard treatment Intervention: Other: standard treatment
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	122
Estimated Completion Date	February 2011
Estimated Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 76 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00949039
Other Study ID Numbers ^ICMJE	PIP2, CSET 1443
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Institut Gustave Roussy
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Institut Gustave Roussy
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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