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

Alternate Title

NCI HIGH PRIORITY CLINICAL TRIAL --- Phase III Randomized Study of Laparoscopic-Assisted Colectomy Versus Open Colectomy for Colon Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	NCCTG-934653 CAN-NCIC-CO12, CLB-9396, E-7293, NSABP-CI64, RTOG-9415, SWOG-9411, INT-0146, NCT00002575, CO11

Trial Description

Purpose:

Less invasive types of surgery may help reduce the number of side effects and improve recovery. It is not yet known which type of surgery is more effective for colon cancer.

Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer.

Eligibility:

• At least 18 years old
• No stage IV cancer
• No rectal cancer
• No Crohn's disease, chronic ulcerative colitis, or familial polyposis
• 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 undergo an open colectomy. Patients in group two will undergo a laparoscopic-assisted colectomy. Patients in group two who are found to have advanced disease during laparoscopy will undergo open surgery to remove the colon. All patients may then be entered on another clinical trial to receive chemotherapy. Quality of life will be assessed periodically. Patients will be evaluated every 3 months for 1 year, every 6 months for 4 years, and once a year for 3 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

North Central Cancer Treatment Group

Heidi Nelson, MD, Protocol chair		Ph: 507-284-3329

Southwest Oncology Group

Robert Beart, MD, Protocol chair		Ph: 323-865-3690; 800-865-0102 Email: rbeart@usc.edu

Eastern Cooperative Oncology Group

Mark Talamonti, MD, Protocol chair		Ph: 312-695-2534

Radiation Therapy Oncology Group

John Skibber, MD, Protocol chair		Ph: 713-792-5165; 800-392-1611

Cancer and Leukemia Group B

Jane Weeks, MD, Protocol chair		Ph: 617-632-2509; 866-790-4500

NCIC-Clinical Trials Group

Hartley Stern, MD, Protocol chair		Ph: 613-737-7700 ext. 70269; 888-627-5346

National Surgical Adjuvant Breast and Bowel Project

Thomas Julian, MD, Protocol chair		Ph: 412-359-8720; 866-680-0004 Email: tjulian@WPAHS.org

Registry Information
Official Title		A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER
Trial Start Date		1994-08-15
Registered in ClinicalTrials.gov		NCT00002575
Date Submitted to PDQ		1994-08-15
Information Last Verified		2002-10-18
NCI Grant/Contract Number		CA65157, CA25224