A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
- 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
- Compare the time to first recurrence in patients treated with these regimens.
- Compare the aesthetic appearance of lesion sites in patients treated with these
- 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
Absence of local recurrence at 3 years after start of treatment
Mara Ozolins, MS
Queen's Medical Centre
United States: Federal Government