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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TERMINATED
PHASE1/PHASE2
46 participants
INTERVENTIONAL
2002-10-31
Brief Summary
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* Phase II: To determine the treatment efficacy according to response rates from phase I.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Oxaliplatin
oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days
Eligibility Criteria
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Inclusion Criteria
* Histological proved rectal adenocarcinoma
* No chemotherapy treatment on the previous 6 months before inclusion.
* No previous pelvic radiotherapy treatment
Exclusion Criteria
* Intestinal occlusion or subocclusion
* Peripheral neuropathy
* Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
* Participation in other trials on the previous 4 months.
18 Years
80 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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José Mª Taboada
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
Barcelona, , Spain
Countries
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Other Identifiers
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L_8330
Identifier Type: -
Identifier Source: org_study_id
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