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Oxaliplatin in Rectal Cancer

NCT00259363 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2009-12-07

No results posted yet for this study

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.

Conditions

  • Rectal Neoplasms

Interventions

DRUG

Oxaliplatin

oxaliplatin 60/mg/m2/15 days, 5-FU 225 mg/m2/day 5 weeks during radiotherapy (RT) 45 Gys/25 days

Sponsors & Collaborators

Principal Investigators

  • José Mª Taboada · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2006-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00259363 on ClinicalTrials.gov