The SINS trial: a randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma.
BACKGROUND
Basal 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
Five 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.


CONCLUSIONS
This 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.


BACKGROUND
Meta-register: NCT00066872, Eudract No. 2004-004506-24, ISRCTN48755084.
Ozolins
Mara
M
Centre of Evidence-Based Dermatology, King's Meadow Campus, Lenton Lane, Nottingham, NG7 2NR, UK. Mara.Ozolins@Nottingham.ac.uk.
Williams
Hywel C
HC
Armstrong
Sarah J
SJ
Bath-Hextall
Fiona J
FJ
D000279:Administration, Cutaneous; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000191:economics / Q000235:genetics / Q000473:pathology / Q000601:surgery*; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005260:Female; D005838:Genotype; D017048:Health Care Costs; D006801:Humans; D000077271:Imiquimod; D008297:Male; D009824:Ointments; D017060:Patient Satisfaction; D010641:Phenotype; D011110:Polymorphism, Genetic; D011446:Prospective Studies; D012008:Recurrence; D012107:Research Design; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000191:economics / Q000235:genetics / Q000473:pathology / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome
D000634:Aminoquinolines; D000970:Antineoplastic Agents; D009824:Ointments; D000077271:Imiquimod
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