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Preoperative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer

NCT00263029 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2009-09-18

No results posted yet for this study

Summary

The purpose of this phase II trial is to determine the efficacy and safety of the combination of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced cancers of the rectum.

Conditions

  • Rectal Neoplasms

Interventions

DRUG

Oxaliplatin

60mg/m² as a 2-hour intravenous infusion every week for 5-6 week

DRUG

Capecitabine

500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart

RADIATION

Radiotherapy

Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions

Sponsors & Collaborators

Principal Investigators

  • Iris CHAN, MD · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2007-03-31

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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 NCT00263029 on ClinicalTrials.gov