Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
NCT ID: NCT00066872
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2002-10-31
2010-04-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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imiquimod
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Queen's Medical Center
OTHER
Principal Investigators
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Mara Ozolins, MS
Role:
Queen's Medical Center
Locations
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Chesterfield Royal Hospital
Chesterfield, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Solihull Hospital
Solihull, England, United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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CRUK-LON-SINS-C7484/A2869
Identifier Type: -
Identifier Source: secondary_id
EU-20205
Identifier Type: -
Identifier Source: secondary_id
CDR0000320513
Identifier Type: -
Identifier Source: org_study_id