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

Alternate Title

Phase III Randomized Study of Selenium in Patients With Adenomatous Colorectal Polyps

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Prevention Active 40 to 80 NCI UARIZ-00-0430-01 00-0430-01, UARIZ-HSC-00142, NCT00078897

Special Category: NCI Web site featured trial

Trial Description

Purpose:

Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps.

This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps.

Eligibility:

Eligibility criteria include the following:

• 40-80 years old
• Must have undergone a colonoscopy within the past 6 months
• No previous diagnosis of colorectal cancer, familial adenomatous polyposis, ulcerative colitis, Crohn's disease, or hereditary nonpolyposis colon cancer
• No more than one previous surgery to remove a section of the colon
• 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 selenium by mouth once a day. Patients in group two will receive a placebo by mouth once a day. Treatment in both groups may continue for up to 5-7.6 years. Patients will undergo a follow-up colonoscopy periodically for approximately 5-7.6 years after the initial colonoscopy.

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

Arizona Cancer Center at University of Arizona Health Sciences Center

M. Peter Lance, MD, Principal investigator		Ph: 520-626-4492; 800-622-2673 Email: plance@azcc.arizona.edu

U.S.A.
Arizona
	Phoenix
	Veterans Affairs Medical Center - Phoenix
		Francisco Ramirez, MD	Ph:  602-264-4461 800-554-7174
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
		Liane Fales, RN	Ph:  602-264-4461
			Email: lfales@email.arizona.edu
	Tucson
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Clinical Trials Office - Arizona Cancer Center at University of Arizona Health Sciences Center	Ph:  520-626-9008
Colorado
	Aurora
	University of Colorado Cancer Center at UC Health Sciences Center
		Dennis Ahnen, MD	Ph:  303-399-8020 x3018
Texas
	Dallas
	Baylor University Medical Center - Dallas
		Clinical Trials Office - Baylor University Medical Center - Dallas	Ph:  800-422-9567

Related Information

Featured trial article

Registry Information
Official Title		Phase III Study of the Effects of Selenium on Adenomatous Polyp Recurrence
Trial Start Date		2001-01-15
Trial Completion Date		2013-03-01 (estimated)
Registered in ClinicalTrials.gov		NCT00078897
Date Submitted to PDQ		2004-01-14
Information Last Verified		2008-11-06
NCI Grant/Contract Number		CA23074, CA41108