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

Non-melanomatous Skin Cancer Clinical Trial

Official title:

A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066872
• Other study ID #: CDR0000320513
• Secondary ID: CRUK-LON-SINS-C7
• Status: Completed
• Phase: Phase 3
• First received: August 6, 2003
• Last updated: September 16, 2013
• Start date: October 2002
• Est. completion date: April 2010

Study information

• Verified date: September 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Basal Cell
• Non-melanomatous Skin Cancer
• Skin Neoplasms

Intervention

Drug:
• imiquimod

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United Kingdom	Chesterfield Royal Hospital	Chesterfield	England
United Kingdom	Queen's Medical Centre	Nottingham	England
United Kingdom	Solihull Hospital	Solihull	England

Sponsors (1)

Lead Sponsor	Collaborator
Queen's Medical Centre

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Ozolins M, Williams HC, Armstrong SJ, Bath-Hextall FJ. The SINS trial: a randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma. Trials. 2010 Apr 21;11:42. doi: 10.1186/1745-6215-11-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of local recurrence at 3 years after start of treatment			No
Secondary	Recurrence of basal cell cancer (BCC) at 1, 2, and 5 years			No
Secondary	Time to first occurrence up to 5 years from completion of study treatment			No
Secondary	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			No
Secondary	Pain at lesion site as measured by 6-point scale daily during treatment, and then 16 weeks after the completion of study treatment			No
Secondary	Cost effectiveness assessed up to 3 or 5 years			No