Oxaliplatin in Rectal Cancer

Phase 1

Terminated

• Conditions: Rectal Neoplasms

• Registration Number: NCT00259363
• Lead Sponsor: Sanofi

Brief Summary

* 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

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2005-11-28
• Study First Submitted QC: 2005-11-28
• Study First Posted: 2005-11-29
• Primary Completion: 2006-06
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Phase I : Maximum Tolerated Dose & Recommended Dose	Days 1, 15, 29
Phase II : Response and resectability rate.	6 cycles in 6 months

Trial Locations

Locations (1)

Sanofi-Aventis; 🇪🇸 Barcelona, Spain