Official Title: “A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Active Control

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.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

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

Intervention(s) in this Clinical Trial

• Drug: imiquimod
• Procedure: conventional surgery

Primary Measures

• Absence of local recurrence at 3 years after start of treatment
  • Safety Issue?: No

Secondary Measures

• Recurrence of basal cell cancer (BCC) at 1, 2, and 5 years
  • Safety Issue?: No
• Time to first occurrence up to 5 years from completion of study treatment
  • Safety Issue?: No
• 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
  • Safety Issue?: No
• Pain at lesion site as measured by 6-point scale daily during treatment, and then 16 weeks after the completion of study treatment
  • Safety Issue?: No
• Cost effectiveness assessed up to 3 or 5 years
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Queen's Medical Centre

Overall Clinical Trial Officials and Contacts

Mara Ozolins, MS Study Chair Queen's Medical Centre  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00066872

Study ID Number: CDR0000320513

ClinicalTrials.gov Identifier: NCT00066872

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database