NCT00066872

Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer

A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Queen's Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

OBJECTIVES: * Compare the rate of local recurrence at 3 years in patients with nodular or superficial basal cell skin cancer treated with imiquimod 5% cream vs excisional surgery. * Compare recurrence at 6 months and 1, 2, and 5 years in patients treated with these regimens. * Compare the time to first recurrence in patients treated with these regimens. * Compare the aesthetic appearance of lesion sites in patients treated with these regimens. * Compare pain in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and lesion type (nodular vs superficial). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive topical imiquimod to a single lesion once daily for 6 weeks for a superficial lesion or 12 weeks for a nodular lesion. Patients with early treatment failure or recurrence are offered surgical excision. * Arm II: Patients undergo surgical excision. Patients are followed at 6, 12, and 18 weeks, every 6 months for 1 year, annually for 2 years, and then at 5 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 18 months.

Conditions

• Non-melanomatous Skin Cancer

Interventions

Type	Name	Description
DRUG	imiquimod
PROCEDURE	conventional surgery

Timeline

• Start date: 2002-10-01
• Completion: 2010-04-01
• First posted: 2003-08-07
• Last updated: 2013-09-17

Locations

3 sites across 1 country: United Kingdom