Oxaliplatin in Rectal Cancer

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Brief Summary

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* Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
* Phase II: To determine the treatment efficacy according to response rates from phase I.

Detailed Description

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Conditions

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Rectal Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ECOG: 0-2
* Histological proved rectal adenocarcinoma
* No chemotherapy treatment on the previous 6 months before inclusion.
* No previous pelvic radiotherapy treatment

Exclusion Criteria

* Important Biological abnormality (renal, hepatic and/or hematological)
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Site Status

Countries

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Spain

Other Identifiers

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L_8330

Identifier Type: -

Identifier Source: org_study_id