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

Phase 1

Completed

• Conditions: Rectal Neoplasms

• Registration Number: NCT00403624
• Lead Sponsor: Sanofi

Brief Summary

Primary objective:

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

Secondary objective:

- tolerability (toxicity) and time to progression

Detailed Description

Not available

Study Timeline

• Study Start: 2001-07
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2006-11-23
• Study First Submitted QC: 2006-11-23
• Study First Posted: 2006-11-27
• Status Verified: 2008-04
• Last Update Submitted: 2010-08-26
• Last Update Posted: 2010-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tumour response

Secondary Outcome Measures

Name	Time	Method
Disease free and Overall survival ; Adverse events