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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
  Purpose

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 Intervention Phase
Gynaecologic or Digestive Pelvic Cancer
 Drug: Isolated pelvis perfusion
Other: standard treatment
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • survival

Estimated Enrollment: 122
Study Start Date: February 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy
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
Standard treatment
 Other: standard treatment
chemotherapy and/or radiotherapy and/or surgery

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949039

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Jane MURET, MD     33 1 42 11 40 18        
Sponsors and Collaborators
Institut Gustave Roussy
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00949039     History of Changes
Other Study ID Numbers: PIP2, CSET 1443
Study First Received: July 7, 2009
Last Updated: August 21, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Pelvic Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013