SWOG-9304 Chemotherapy Plus Radiation Therapy in Treating Patients With Rectal Cancer That Has Been Surgically Removed

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which treatment regimen is more effective for rectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus radiation therapy in treating patients who have rectal cancer that has been surgically removed.

Conditions

• Colorectal Cancer

Interventions

DRUG

fluorouracil

See arm assignments.

DRUG

leucovorin calcium

See arm assignments.

DRUG

levamisole hydrochloride

See arm assignments.

RADIATION

radiation therapy

See arm assignments.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• Radiation Therapy Oncology Group

  collaborator NETWORK

• North Central Cancer Treatment Group

  collaborator NETWORK

• NCIC Clinical Trials Group

  collaborator NETWORK

• Cancer and Leukemia Group B

  collaborator NETWORK

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Stephen R. Smalley, MD · University of Kansas

• Al B. Benson, MD, FACP · Robert H. Lurie Cancer Center

• Jaffer A. Ajani, MD · M.D. Anderson Cancer Center

• Michael J. O'Connell, MD · Mayo Clinic

• Anthony LA Fields, MD, FRCPC · Cross Cancer Institute at University of Alberta

• Robert J. Mayer, MD, FACP · Dana-Farber Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1994-03-31

Primary Completion

2006-08-31

Completion

2008-10-31

Countries

• United States
• Canada
• South Africa

Study Locations