Condition category
Cancer
Date applied
31/03/2010
Date assigned
31/03/2010
Last edited
15/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Mara Ozolins

ORCID ID

Contact details

Centre of Evidence Based Dermatology
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

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

http://www.nottingham.ac.uk/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes