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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

A Phase III Randomized Double-Blind Study of Adjuvant Imatinib Mesylate (Gleevec; STI571) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor (GIST)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	ACOSOG-Z9001 CAN-NCIC-SRC1, CALGB-ACOSOG-Z9001, SWOG-ACOSOG-Z9001, NCT00041197, UWCC-UW-6303, UWCC-UW-03-8438-A-03, SRC1

Special Category: CTSU trial

Trial Description

Purpose:

Imatinib mesylate (Gleevec; STI571) may interfere with the growth of tumor cells and may be an effective treatment for patients with primary gastrointestinal stromal tumor that has been completely removed by surgery.

This randomized phase III trial is studying imatinib mesylate (Gleevec; STI571) to see how well it works compared to placebo in treating patients with primary gastrointestinal stromal tumor that has been completely removed by surgery.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No more than 10 weeks since surgery to remove the tumor
• No peritoneal or distant metastases
• No chemotherapy or radiation therapy following surgery
• No previous imatinib mesylate (Gleevec; STI571)
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Patients in group one will receive imatinib mesylate (Gleevec; STI571) by mouth once a day for 1 year. Some patients may receive imatinib mesylate (Gleevec; STI571) for as long as benefit is shown. Patients in group two will receive a placebo by mouth once a day for 1 year. Some patients may also receive imatinib mesylate (Gleevec; STI571) as in group one.

Patients will be evaluated every 3 months for 2 years and every 6 months for 8 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Ronald DeMatteo, MD, Protocol chair		Ph: 212-639-5726; 800-525-2225 Email: dematter@mskcc.org

NCIC-Clinical Trials Group

Martin Blackstein, MD, Protocol chair		Ph: 416-586-5371 Email: martin.blackstein@utoronto.ca

Cancer and Leukemia Group B

Christopher Ryan, MD, Protocol chair(Contact information may not be current)		Ph: 773-702-9200; 888-824-0200

Southwest Oncology Group

John Vetto, MD, FACS, Protocol chair		Ph: 503-494-5501; 800-494-1234 Email: vettoj@ohsu.edu

Registry Information
Official Title		A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary GastroIntestinal Stromal Tumor (GIST)
Trial Start Date		2002-06-01
Trial Completion Date		2018-04-18 (estimated)
Registered in ClinicalTrials.gov		NCT00041197
Date Submitted to PDQ		2002-05-16
Information Last Verified		2008-08-25
NCI Grant/Contract Number		CA76001

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