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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00949039
First received: July 7, 2009
Last updated: March 11, 2015
Last verified: March 2015
  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
Radiation: radiotherapy
Procedure: Surgery
Phase 3

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

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Survival rate [ Time Frame: From randomization to death ] [ Designated as safety issue: Yes ]

Enrollment: 101
Study Start Date: February 2009
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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
Radiation: radiotherapy
chemotherapy and/or radiotherapy and/or surgery
Procedure: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT00949039     History of Changes
Other Study ID Numbers: PIP2, CSET 1443
Study First Received: July 7, 2009
Last Updated: March 11, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on July 01, 2015