A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
N/A
N/A
Both
Non-melanomatous Skin Cancer
Trial Information
A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary basal cell skin carcinoma
- Nodular or superficial lesion(s)*
- Located in low-risk areas NOTE: *Any number of lesions are allowed but only 1
lesion per patient is selected for the study
- No genetic or nevoid conditions (e.g., Gorlin's syndrome)
- No morphoeic (microinfiltrative) histology
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- No bleeding disorder
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 1 month after
study participation
- No allergy to any of the study interventions
- No life-threatening disease
- Must be available for study follow-up for up to 3 years
- Must have access to a telephone
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent participation in any other experimental trial
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Absence of local recurrence at 3 years after start of treatment
Safety Issue:
No
Principal Investigator
Mara Ozolins, MS
Investigator Affiliation:
Queen's Medical Centre
Authority:
United States: Federal Government
Study ID:
CDR0000320513
NCT ID:
NCT00066872
Start Date:
October 2002
Completion Date:
Related Keywords:
- Non-melanomatous Skin Cancer
- basal cell carcinoma of the skin
- Skin Neoplasms
- Carcinoma, Basal Cell
Name | Location |
|---|
