Non-melanomatous Skin Cancer Clinical Trial
Official title:
A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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