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
NCT ID: NCT00949039
Last Updated: 2015-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
101 participants
INTERVENTIONAL
2009-02-28
2014-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy
Isolated pelvis perfusion
Isolated pelvis perfusion
injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg
Control
Standard treatment
radiotherapy
chemotherapy and/or radiotherapy and/or surgery
Surgery
Interventions
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Isolated pelvis perfusion
injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg
radiotherapy
chemotherapy and/or radiotherapy and/or surgery
Surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* Cardiac or vascular pathology
* Pulmonary disease
* Uncontrolled Sepsis disease
* Pregnancy
18 Years
76 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Locations
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Institut Gustave Roussy
Villejuif, , France
Countries
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Related Links
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Related Info
Other Identifiers
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CSET 1443
Identifier Type: -
Identifier Source: secondary_id
PIP2
Identifier Type: -
Identifier Source: org_study_id
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