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Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer

NCT00227747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 598

Last updated 2021-02-17

No results posted yet for this study

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer.

Conditions

Interventions

DRUG

capecitabine

DRUG

oxaliplatin

PROCEDURE

conventional surgery

PROCEDURE

neoadjuvant therapy

RADIATION

radiation therapy

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Jean-Pierre Gerard, MD · Centre Antoine Lacassagne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-11-08
Primary Completion
2008-10-22
Completion
2013-07-15

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

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 NCT00227747 on ClinicalTrials.gov