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Radiation Therapy With or Without Chemotherapy Before Surgery in Treating Patients With Stage II or Stage III Rectal Cancer

NCT00296608 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 762

Last updated 2016-05-30

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 fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without chemotherapy when given before surgery for rectal cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy given together with fluorouracil and leucovorin to see how well they work compared to giving radiation therapy alone before surgery in treating patients with stage II or stage III rectal cancer.

Conditions

Interventions

DRUG

fluorouracil

DRUG

leucovorin calcium

PROCEDURE

conventional surgery

RADIATION

radiation therapy

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    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
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-04-30
Primary Completion
2008-08-31
Completion
2008-08-31

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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 NCT00296608 on ClinicalTrials.gov