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: Randomized phase III trial to compare the effectiveness of topical imiquimod with that of surgery in treating patients who have basal cell skin cancer.

Condition	Treatment or Intervention	Phase
basal cell carcinoma of the skin	Drug: imiquimod  Procedure: biological response modifier therapy  Procedure: conventional surgery  Procedure: non-specific immune-modulator therapy  Procedure: surgery	Phase III

Further Study Details: 

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 (patients with nodular lesions only) weeks, every 6 months for 1 year, annually for 2 years, and then at 5 years.

PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this study within 18 months.

Genders Eligible for Study:  Both

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

United Kingdom, England
      Chesterfield Royal Hospital, Chesterfield,  England,  S44 5BL,  United Kingdom; Recruiting
      Queen's Medical Centre, Nottingham,  England,  NG7 2UH,  United Kingdom; Recruiting
      Solihull Hospital, Solihull,  England,  B91 2JL,  United Kingdom; Recruiting

Study chairs or principal investigators

Mara Ozolins, MS,  Study Chair,  Queen's Medical Centre   

Study ID Numbers:  CDR0000320513; CRUK-LON-SINS-C7484/A2869; EU-20205; NCT00066872
Record last reviewed:  July 2003
Last Updated:  December 6, 2004
Record first received:  August 6, 2003
ClinicalTrials.gov Identifier:  NCT00066872
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08