Evaluation of the Neoadjuvant Treatment With Oxaliplatin -UFT- Radiotherapy in Rectal Cancer

NCT ID: NCT00403624

Last Updated: 2010-08-27

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2005-11-30

Brief Summary

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Primary objective:

\- To evaluate the rate of responses to neoadjuvant therapy + radiotherapy

Secondary objective:

\- tolerability (toxicity) and time to progression

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with measurable, histologically proven rectal cancer.
* No history of previous malignancy but adequately treated skin / cervical cancer.
* Adequate haematological, renal and liver function.

Exclusion Criteria

* No cardiopulmonary insufficiency or coronary disease. No sensory neuropathy prior to study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Principal Investigators

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José Mª Taboada, Dr.

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

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L_8128

Identifier Type: -

Identifier Source: org_study_id

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