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

Alternate Title

Phase II Randomized Chemoprevention Study of Sulindac in Current or Former Smokers With Bronchial Dysplasia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Biomarker/Laboratory analysis, Prevention Active 40 to 79 NCI MAYO-03-1-02 MAY03-1-02, NCT00368927

Trial Description

Purpose:

Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent lung cancer from forming in patients with bronchial dysplasia. It is not yet known whether sulindac is more effective than a placebo in preventing lung cancer in patients with bronchial dysplasia.

This randomized phase II trial is studying sulindac to see how well it works compared to a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia.

Eligibility:

Eligibility criteria include the following:

• 45-79 years old
• Smokes or used to smoke one pack of cigarettes a day for at least 30 years, two packs a day for at least 15 years, or three packs a day for at least 10 years
• No previous lung cancer or had previous stage I non-small lung cancer that was removed by surgery or that was treated with chemotherapy at least 1 year ago
• No carcinoma in situ
• At least 6 months since participating in a chemoprevention clinical trial
• No previous surgery to remove an entire lung
• No previous organ transplant
• 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 (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive sulindac by mouth twice a day for 6 months.

Patients in group two will receive a placebo by mouth twice a day for 6 months.

Patients will undergo bronchoscopy and tissue biopsy before and after treatment for laboratory studies.

After finishing treatment, patients will be evaluated for up to 1 month.

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

Mayo Clinic Cancer Center

James Jett, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

U.S.A.
Florida
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Clinical Trials Office - H. Lee Moffitt Cancer Center and Reseach Institute	Ph:  800-456-7121
			Email: canceranswers@moffitt.org
Massachusetts
	Burlington
	Lahey Clinic Medical Center - Burlington
		Clinical Trials Office - Lahey Clinic Medical Center - Burlington	Ph:  781-744-8027
Michigan
	Detroit
	Josephine Ford Cancer Center at Henry Ford Hospital
		Michael Simoff, MD	Ph:  313-916-4406 888-734-5322
			Email: msimoff1@hfhs.org
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
Canada
British Columbia
	Vancouver
	British Columbia Cancer Agency - Vancouver Cancer Centre
		Stephen Lam, MD	Ph:  604-877-6000 ext. 2080

Registry Information
Official Title		Randomized, Phase IIb Trial of Sulindac in Smokers with Bronchial Dysplasia
Trial Start Date		2006-08-04
Trial Completion Date		2010-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00368927
Date Submitted to PDQ		2006-07-13
Information Last Verified		2009-01-06
NCI Grant/Contract Number		CN35000