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 Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00949039
First received: July 7, 2009
Last updated: August 21, 2009
Last verified: August 2009

July 7, 2009
August 21, 2009
February 2009
February 2011   (final data collection date for primary outcome measure)
survival
Same as current
Complete list of historical versions of study NCT00949039 on ClinicalTrials.gov Archive Site
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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
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gynaecologic or Digestive Pelvic Cancer
  • 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
  • Experimental: Chemotherapy
    Isolated pelvis perfusion
    Intervention: Drug: Isolated pelvis perfusion
  • Active Comparator: Control
    Standard treatment
    Intervention: Other: standard treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
122
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 76 Years
No
France
 
NCT00949039
PIP2, CSET 1443
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Gustave Roussy, Cancer Campus, Grand Paris
Not Provided
Not Provided
Gustave Roussy, Cancer Campus, Grand Paris
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP