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

Alternate Title

Phase III Randomized Study of Topical Imiquimod Versus Excisional Surgery in Patients With Nodular or Superficial Basal Cell Skin Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Any age	Other	CRUK-LON-SINS-C7484/A2869 EU-20205, NCT00066872

Trial Description

Purpose:

Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer.

This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.

Eligibility:

Eligibility criteria include the following:

• Any age
• No genetic disorder or nevus disorder, such as Gorlin syndrome
• 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 apply topical imiquimod to one lesion once a day for 6-12 weeks. Some patients may undergo surgery.

Patients in group two will undergo surgery to remove the lesion.

Patients will be evaluated at 6, 12, and 18 weeks, every 6 months for 1 year, once a year for 2 years, and at 5 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

Queen's Medical Centre

Mara Ozolins, MS, Study coordinator		Ph: 44-115-846-8624

Registry Information
Official Title		A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
Trial Start Date		2002-10-01
Registered in ClinicalTrials.gov		NCT00066872
Date Submitted to PDQ		2003-07-07
Information Last Verified		2009-09-09

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