The SINS trial: A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinomaReport as inadecuate




The SINS trial: A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma - Download this document for free, or read online. Document in PDF available to download.

Trials

, 11:42

First Online: 21 April 2010Received: 18 February 2010Accepted: 21 April 2010DOI: 10.1186-1745-6215-11-42

Cite this article as: Ozolins, M., Williams, H.C., Armstrong, S.J. et al. Trials 2010 11: 42. doi:10.1186-1745-6215-11-42

Abstract

BackgroundBasal cell carcinoma is the commonest human cancer. Despite increasing incidence it remains poorly researched. While not life threatening it can cause significant cosmetic disfigurement. Imiquimod, a cream which enhances the body-s immune response, may help deal with the number of cases that occur in low-risk sites, especially when good cosmetic results and home use without surgery are needed.

This study aims 1. To compare excisional surgery with imiquimod cream for nodular or superficial basal cell carcinoma in low risk sites, with respect to 3 year clinical clearance, cost-effectiveness and cosmetic results. 2. To ascertain if certain phenotypic features and gene polymorphisms predict tumour responsiveness to treatment.

Methods-DesignFive hundred participants with low risk nodular or superficial basal cell carcinoma will be recruited from hospitals to this multi-centre, randomised, parallel group, controlled phase III trial. Treatment in the imiquimod group is for 6 weeks for superficial basal cell carcinoma and 12 weeks for nodular basal cell carcinoma. Both treatment groups are followed up in clinic for 3 years. Primary outcome variable: the proportion of participants with clinical evidence of success no recurrence at 3 years. The primary outcome will be compared between the two treatment groups. Secondary outcomes include: i clinical success at 1, 2 and 5 years, ii time to first recurrence, iii cosmetic appearance of lesion site after treatment, iv level of pain, and v cost-effectiveness. Safety and tolerability data will also be reported.

DiscussionThis study protocol describes a pragmatic randomised controlled trial which it is hoped will address the above uncertainties. Three-year results will be available towards the end of 2010.

Trial registrationMeta-register: NCT00066872, Eudract No. 2004-004506-24, ISRCTN48755084.

AbbreviationsBCCbasal cell carcinoma

RCTrandomised controlled clinical trial.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-11-42 contains supplementary material, which is available to authorized users.

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Author: Mara Ozolins - Hywel C Williams - Sarah J Armstrong - Fiona J Bath-Hextall

Source: https://link.springer.com/







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