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Clinical Trials/NCT00403624
NCT00403624CompletedPhase 1

Clinical Study to Evaluate a Protocol of Oxaliplatin -UFT- Radiotherapy for the Neoadjuvant Treatment Rectal Cancer

Sanofi0 sites38 target enrollmentStarted: July 2001Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Sanofi
Enrollment
38
Primary Endpoint
Tumour response
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Primary objective:

  • To evaluate the rate of responses to neoadjuvant therapy + radiotherapy

Secondary objective:

  • tolerability (toxicity) and time to progression

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Tumour response

Secondary Outcomes

  • Disease free and Overall survival ; Adverse events

Investigators

Sponsor
Sanofi
Sponsor Class
Industry

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