5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
NCT ID: NCT00189657
Last Updated: 2005-09-19
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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UNKNOWN
PHASE3
INTERVENTIONAL
Brief Summary
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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
Interventions
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5FU/LV Mayo Clinic or LV5FU2
LV5FU2 + irinotecan
Eligibility Criteria
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Inclusion Criteria
* R0 surgery
* T3, N0, M0 or T4, N0, M0 or N1,2, M0
* chemotherapy can be started within 8 weeks after surgery
* Age \> 18
* Performance status ECOG \< 3
* preoperative radiotherapy allowed
* preoperative chemotherapy with 5FU +/- LV allowed
* Neutrophiles \> 1 500/mm3; Pl. \> 100 000/mm3
* Transaminases \< 2 x UNL; Alcalines Phosphatases \< 2 x UNL; Bili \< 1.1 UNL
* creatininemia \< 120 µmol/l and/or clearance of creatininemia \> 60 ml/mn
* Written informed consent before inclusion
Exclusion Criteria
* Distant metastases
* Contraindication to any drug contained in the chemotherapy regimens
* Any serious active disease or co-morbid medical condition including digestive inflammatory disease
* Gilbert disease
* severe toxicity of radiotherapy
* Pregnancy or breast feeding
* Absence of contraception in non menopausal women
* Adult patient unable to give informed consent because of intellectual impairment
* Concomitant participation to another trial
18 Years
ALL
No
Sponsors
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Aventis Pharmaceuticals
INDUSTRY
Pfizer
INDUSTRY
Association Européenne de Recherche en Oncologie
OTHER
Principal Investigators
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Pascal Piedbois, MD
Role: PRINCIPAL_INVESTIGATOR
Association Europeenne de Recherche en Oncologie
Thierry Andre, MD
Role: PRINCIPAL_INVESTIGATOR
GERCOR - Multidisciplinary Oncology Cooperative Group
Alain Piolot, MD
Role: PRINCIPAL_INVESTIGATOR
Association Europeenne de Recherche en Oncologie
Emmanuel Achille, MD
Role: PRINCIPAL_INVESTIGATOR
GERCOR - Multidisciplinary Oncology Cooperative Group
Iradj Bobhani, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Française de Cancérologie Digestive
Jean-Yves Douillard, MD
Role: PRINCIPAL_INVESTIGATOR
UNICANCER
Locations
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AERO
Créteil, , France
Countries
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Central Contacts
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Facility Contacts
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Pascal Piedbois, MD
Role: primary
Other Identifiers
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AERO-R98
Identifier Type: -
Identifier Source: org_study_id