Plain English Summary
Trial website
Additional identifiers
EudraCT number
2004-004506-24
ClinicalTrials.gov number
NCT00066872
Protocol/serial number
1066
Study information
Scientific title
A randomised controlled trial of the effectiveness of excisional surgery versus imiquimod 5% cream for long-term clinical success rate in patients with nodular and superficial basal cell carcinoma
Acronym
SINS
Study hypothesis
1. Can imiquimod 5% cream applied topically give an acceptable and clinically useful success rate (3 year clinical clearance) and acceptable side effect profile when compared with excision surgery for superficial and nodular basal cell carcinoma (BCC) at low risk sites?
2. Is imiquimod more cost effective than surgery for low-risk BCC?
3. Does imiquimod result in a more aesthetically acceptable result than conventional excision?
4. Do certain phenotypic features and gene polymorphisms predict tumour responsiveness to treatment?
Ethics approval
Queen's Medical Centre, Nottingham (now Nottingham Research Ethics Committee 2), 15/11/2001, ref: LREC:DE090101
Study design
Randomised interventional multicentre treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Melanoma; Disease: Skin
Intervention
Simple excisional surgery with a 4 mm margin versus imiquimod 5% cream (Aldara) applied once daily for 6 weeks for superficial BCC and 12 weeks for nodular BCC.
Follow Up Length: 36 months (60 months from records)
Study Entry: Single Randomisation only
Last patient recruited: 22/02/2007
Intervention type
Drug
Phase
Phase III
Drug names
Imiquimod 5% cream
Primary outcome measures
Clinical evidence of success (absence of any signs of local recurrence) at 3 years
Secondary outcome measures
1. Recurrence at 1, 2 and 5 years
2.Time to first recurrence
3. Aesthetic appearance of lesion site
4. Daily pain during and for 16 weeks post-treatment
5. Cost effectiveness
Overall trial start date
19/06/2003
Overall trial end date
23/04/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Primary nodular or superficial basal cell carcinoma located in low risk area
2. Access to telephone
3. Histologically proven BCC
Male or female participants of any age were recruited.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Planned sample size: 500; Actual sample size: 501
Participant exclusion criteria
1. Genetic or nevoid conditions e.g., Gorlin's syndrome
2. Morphoeic (microinfiltrative) as diagnosed clinically
3. Allergy to any of the interventions
4. Involvement in a trial of another experimental intervention
5. Life threatening disease
6. Bleeding disorders
7. Unavailable for 3 years follow-up
8. Pregnant or breastfeeding
Recruitment start date
19/06/2003
Recruitment end date
22/02/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre of Evidence Based Dermatology
Nottingham
NG7 2NR
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
University Park
Nottingham
NG7 2RD
United Kingdom
-
Paul.Cartledge@Nottingham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C7484/A2869; C7484/A8991)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20409337
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23035730
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24332516
Publication citations
-
Protocol
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, 11, 42, doi: 10.1186/1745-6215-11-42.
-
Results
Tinelli M, Ozolins M, Bath-Hextall F, Williams HC, What determines patient preferences for treating low risk basal cell carcinoma when comparing surgery vs imiquimod? A discrete choice experiment survey from the SINS trial., BMC Dermatol., 2012, 12, 19, doi: 10.1186/1471-5945-12-19.
-
Results
Bath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PS, Williams HC, , Surgical excision versus imiquimod 5% cream for nodular and superficial basal-cell carcinoma (SINS): a multicentre, non-inferiority, randomised controlled trial., Lancet Oncol., 2014, 15, 1, 96-105, doi: 10.1016/S1470-2045(13)70530-8.