Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Any age Other CRUK-LON-SINS-C7484/A2869 EU-20205, NCT00066872

Objectives

1. 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.
2. Compare recurrence at 6 months and 1, 2, and 5 years in patients treated with these regimens.
3. Compare the time to first recurrence in patients treated with these regimens.
4. Compare the aesthetic appearance of lesion sites in patients treated with these regimens.
5. Compare pain in patients treated with these regimens.

Entry 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

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

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

Expected Enrollment

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

Outcomes

Absence of local recurrence at 3 years after start of treatment

Recurrence of basal cell cancer (BCC) at 1, 2, and 5 years
Time to first occurrence up to 5 years from completion of study treatment
Aesthetic appearance of lesion site as measured by participant and blind observer using 5-point Likert scale at 6 months, and then years 1-3
Pain at lesion site as measured by 6-point scale daily during treatment, and then 16 weeks after the completion of study treatment
Cost effectiveness assessed up to 3 or 5 years

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.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Trial Contact Information

Trial Lead Organizations

Queen's Medical Centre

Mara Ozolins, MS, Protocol chair		Ph: 44-115-924-9924 ext. 43250

Registry Information
Official Title		A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
Trial Start Date		2002-10-01
Registered in ClinicalTrials.gov		NCT00066872
Date Submitted to PDQ		2003-07-07
Information Last Verified		2007-06-25

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