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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

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ClinicalTrials.gov Identifier: NCT00949039
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : March 12, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Gynaecologic or Digestive Pelvic Cancer Drug: Isolated pelvis perfusion Radiation: radiotherapy Procedure: Surgery Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2009
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Melphalan
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Radiation: radiotherapy
chemotherapy and/or radiotherapy and/or surgery
Procedure: Surgery


Outcome Measures

Primary Outcome Measures :
  1. Survival rate [ Time Frame: From randomization to death ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949039


Locations
France
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
More Information

Additional Information:
Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT00949039     History of Changes
Other Study ID Numbers: PIP2
CSET 1443
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Pelvic Neoplasms
Neoplasms by Site
Neoplasms
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs