Clinical trial NCT00066872: Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
Official title: A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-melanomatous Skin Cancer
Keywords: basal cell carcinoma of the skin
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-08-07
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Absence of local recurrence at 3 years after start of treatment
Secondary outcomes:
measure: Recurrence of basal cell cancer (BCC) at 1, 2, and 5 years
measure: Time to first occurrence up to 5 years from completion of study treatment
measure: 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
measure: Pain at lesion site as measured by 6-point scale daily during treatment, and then 16 weeks after the completion of study treatment
measure: Cost effectiveness assessed up to 3 or 5 years
Other outcomes:
Locations:
city: Chesterfield
country: United Kingdom
facility: Chesterfield Royal Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
city: Solihull
country: United Kingdom
facility: Solihull Hospital
state: England
Study officials:
affiliation: Queen's Medical Center
name: Mara Ozolins, MS
References:
citation: 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.
citation: Williams HC, Bath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PSJ; Surgery Versus Imiquimod for Nodular and Superficial Basal Cell Carcinoma (SINS) Study Group. Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial. J Invest Dermatol. 2017 Mar;137(3):614-619. doi: 10.1016/j.jid.2016.10.019. Epub 2016 Dec 5.
citation: Bath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PS, Williams HC; Surgery versus Imiquimod for Nodular Superficial basal cell carcinoma (SINS) study group. Surgical excision versus imiquimod 5% cream for nodular and superficial basal-cell carcinoma (SINS): a multicentre, non-inferiority, randomised controlled trial. Lancet Oncol. 2014 Jan;15(1):96-105. doi: 10.1016/S1470-2045(13)70530-8. Epub 2013 Dec 11.