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

Queen's Medical Center

Status and phase

Completed

Phase 3

Conditions

Non-melanomatous Skin Cancer

Treatments

Procedure: conventional surgery

Drug: imiquimod

Study type

Interventional

Funder types

Other

Identifiers

NCT00066872

EU-20205

CDR0000320513

CRUK-LON-SINS-C7484/A2869

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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