Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001083987
Ethics application status
Approved
Date submitted
30/09/2011
Date registered
19/10/2011
Date last updated
15/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma.
Scientific title
A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma; primary outcome is success (no treatment failure or recurrence) at 3 years.
Secondary ID [1] 262446 0
Cochrane Skin Group Trial No 18
Secondary ID [2] 262864 0
ISRCTN48755084
Secondary ID [3] 262865 0
Eudract No. 2004-004506-24
Secondary ID [4] 262866 0
Meta-register: NCT00066872 (Clinical trials.gov)
Secondary ID [5] 262867 0
1066 (UKRCN)
Universal Trial Number (UTN)
Trial acronym
SINS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low risk superficial basal cell carcinoma 268139 0
low risk nodular basal cell carcinoma 268140 0
Condition category
Condition code
Skin 270752 270752 0 0
Dermatological conditions
Cancer 270753 270753 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Imiquimod cream 5% applied 7 times per week (daily at night) for 6 weeks for superficial BCC and 12 weeks for nodular BCC. A thin layer was to be applied to the BCC and 1cm surrounding it, gently rubbed in until the cream vanished, and washed off the following morning.
Intervention code [1] 269213 0
Treatment: Drugs
Comparator / control treatment
The surgery for the basal cell skin cancers in this study was scalpel excisional surgery with 4 mm margins performed under local anaesthetic . Primary closure was achieved with sutures. The average duration of the surgery was approximately 15 minutes.
Only if surgery fails (eg histology shows that the 4mm margins have missed some of the BCC), or at some stage during the study the BCC appears to have recurred (confirmed first with a biopsy) will surgery be repeated.
Control group
Active

Outcomes
Primary outcome [1] 269007 0
Absence of treatment failure or any signs of local recurrence at 3 years as judged by the consultant dermatologist (=success)
Timepoint [1] 269007 0
3 years
Secondary outcome [1] 276793 0
Absence of treatment failure or any signs of local recurrence as judged by the consultant dermatologist (=success)
Timepoint [1] 276793 0
1 year (clinical assessment), 2yrs (clinical assessment), 5yrs (from notes only)
Secondary outcome [2] 287671 0
Time to recurrence. This is worked out from the success assessments (primary outcome and secondary outcome 1).
Timepoint [2] 287671 0
Time to recurrence is in time intervals as assessments are only made at intervals (up to 1 year, 1-2years, 2-3years, 3-5 years, >5years); up to 3 years by clinical assessment, 3-5 years from patient notes (hospital, GP and pathology).
Secondary outcome [3] 287672 0
Aesthetic appearance of lesion site (as assessed by patient [5-point scale, excellent to very poor) and blinded assessor [5-point scale, as for participant, also features of appearance. Assessments made from photographs]).
Timepoint [3] 287672 0
Patient assessments made from month 6 on, blinded assessor at month 6 and year 3.

Eligibility
Key inclusion criteria
People with low risk superficial or nodular basal cell carcinoma (histologically proven basal cell carcinoma)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Genetic/nevoid conditions e.g. Gorlin's syndrome.
Morphoeic (microinfiltrative) trial lesion as diagnosed clinically.
Allergy to any of the interventions.
Involvement in a trial of another experimental intervention.
Life threatening disease.
Patients with bleeding disorders.
Patients not available for follow up for 3 yrs.
Pregnant, intention to become pregnant during treatment phase of the trial, or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants were invited by the hospital dermatologist to see a study research nurse. The nurse explained the study, and checked eligibility for those interested. Consent was obtained at a separate visit .
The allocation is obtained at the baseline visit, using a central telephone randomisation service run by independent staff at the Trent RDSU. This ensured concealment of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A pre-prepared randomisation schedule was generated by computer at the Trent Research and Development Support Unit (Trent RDSU). Randomisation was stratified according to lesion type (nodular or superficial, defined clinically) and by centre, thus minimising the differences in the most important predictor baseline variables. There was no attempt to equalise numbers of nodular and superficial BCCs randomised.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blinded assessment of cosmetic appearance done from photographs.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
19/06/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 3641 0
United Kingdom
State/province [1] 3641 0

Funding & Sponsors
Funding source category [1] 269682 0
Charities/Societies/Foundations
Name [1] 269682 0
Cancer Research UK
Country [1] 269682 0
United Kingdom
Primary sponsor type
University
Name
University of Nottingham
Address
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
Country
United Kingdom
Secondary sponsor category [1] 266352 0
None
Name [1] 266352 0
Address [1] 266352 0
Country [1] 266352 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271636 0
East Midlands - Nottingham 2 Research Ethics Committee
Ethics committee address [1] 271636 0
The Old Chapel
Royal Standard Place
Nottingham
NG1 6FS
Ethics committee country [1] 271636 0
United Kingdom
Date submitted for ethics approval [1] 271636 0
Approval date [1] 271636 0
15/11/2001
Ethics approval number [1] 271636 0
DE090101. Ethics committee 1 is the main ethics committee, through which all correspondance goes. Same HREC number for all post-COREC recruited centres.
Ethics committee name [2] 271637 0
North Derbyshire LREC
Ethics committee address [2] 271637 0
Ethics committee country [2] 271637 0
United Kingdom
Date submitted for ethics approval [2] 271637 0
Approval date [2] 271637 0
16/09/2002
Ethics approval number [2] 271637 0
Ref 791 used early on before COREC and main REC identified, now DE090101
Ethics committee name [3] 271638 0
Solihull LREC
Ethics committee address [3] 271638 0
Ethics committee country [3] 271638 0
United Kingdom
Date submitted for ethics approval [3] 271638 0
Approval date [3] 271638 0
26/09/2002
Ethics approval number [3] 271638 0
Ref P52/01 used early on before COREC and main REC identified, now DE090101
Ethics committee name [4] 271639 0
East London and The City HA Local REC 1
Ethics committee address [4] 271639 0
Ethics committee country [4] 271639 0
United Kingdom
Date submitted for ethics approval [4] 271639 0
Approval date [4] 271639 0
29/09/2005
Ethics approval number [4] 271639 0
DE090101
Ethics committee name [5] 271640 0
Lanarkshire LREC
Ethics committee address [5] 271640 0
Ethics committee country [5] 271640 0
United Kingdom
Date submitted for ethics approval [5] 271640 0
Approval date [5] 271640 0
29/07/2005
Ethics approval number [5] 271640 0
DE090101
Ethics committee name [6] 271641 0
Liverpool Paediatric REC
Ethics committee address [6] 271641 0
Ethics committee country [6] 271641 0
United Kingdom
Date submitted for ethics approval [6] 271641 0
Approval date [6] 271641 0
01/07/2005
Ethics approval number [6] 271641 0
DE090101
Ethics committee name [7] 271642 0
Lincolnshire REC
Ethics committee address [7] 271642 0
Ethics committee country [7] 271642 0
United Kingdom
Date submitted for ethics approval [7] 271642 0
Approval date [7] 271642 0
31/03/2005
Ethics approval number [7] 271642 0
DE090101
Ethics committee name [8] 271643 0
South Glasgow REC
Ethics committee address [8] 271643 0
Ethics committee country [8] 271643 0
United Kingdom
Date submitted for ethics approval [8] 271643 0
Approval date [8] 271643 0
02/03/2005
Ethics approval number [8] 271643 0
DE090101
Ethics committee name [9] 271644 0
Dorset REC
Ethics committee address [9] 271644 0
Ethics committee country [9] 271644 0
United Kingdom
Date submitted for ethics approval [9] 271644 0
Approval date [9] 271644 0
01/02/2005
Ethics approval number [9] 271644 0
DE090101
Ethics committee name [10] 271645 0
Argyll and Clyde LREC
Ethics committee address [10] 271645 0
Ethics committee country [10] 271645 0
United Kingdom
Date submitted for ethics approval [10] 271645 0
Approval date [10] 271645 0
17/01/2005
Ethics approval number [10] 271645 0
DE090101
Ethics committee name [11] 271646 0
Sandwell and West Birmingham LREC
Ethics committee address [11] 271646 0
Ethics committee country [11] 271646 0
United Kingdom
Date submitted for ethics approval [11] 271646 0
Approval date [11] 271646 0
30/03/2006
Ethics approval number [11] 271646 0
DE090101
Ethics committee name [12] 271647 0
North Nottinghamshire LREC
Ethics committee address [12] 271647 0
Ethics committee country [12] 271647 0
United Kingdom
Date submitted for ethics approval [12] 271647 0
Approval date [12] 271647 0
10/02/2004
Ethics approval number [12] 271647 0
Ref NNHA/743 used early on before COREC and main REC identified, now DE090101

Summary
Brief summary
This is an independent study (a randomised controlled trial) of imiquimod cream versus surgery in low risk basal cell carcinoma (or "rodent ulcer"). Basal cell carcinoma (BCC) is the commonest cancer in humans. BCCs are slow growing and rarely spread to other sites of the body, but can be unsightly and can bleed. They are usually treated by minor surgery (current “gold standard”) or freezing with liquid nitrogen, but dermatologists and plastic surgeons are constantly on the look-out for other simple but effective treatments. Imiquimod 5% cream stimulates the body's immune system and has been used successfully to treat genital warts, and more recently BCCs.
This is a large definitive study comparing imiquimod to local surgery. Studies previous to this study were smaller, often looking just at initial success rather than whether the BCC returns in the long term. This study aims to show how effective imiquimod is in terms of percentage cure of basal cell carcinoma, three years after treatment, when compared with conventional surgery, and whether the cosmetic result of a cream that patients can apply themselves is any better than surgery.
Trial website
Trial related presentations / publications
Summary protocol: Ozolins, Mara; Williams, Hywel C; Armstrong, Sarah J and Bath-Hextall, Fiona J. The SINS trial: A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma. Trials, 2010, 11(1), 42
Public notes

Contacts
Principal investigator
Name 32774 0
Address 32774 0
Country 32774 0
Phone 32774 0
Fax 32774 0
Email 32774 0
Contact person for public queries
Name 16021 0
Hywel Williams
Address 16021 0
Centre of Evidence based dermatology, Queen's Medical centre, Nottingham, NG7 2UH
Country 16021 0
United Kingdom
Phone 16021 0
+44 115 924 9924 ext31047
Fax 16021 0
+44 115 924 9924 x31046
Email 16021 0
hywel.williams@nottingham.ac.uk
Contact person for scientific queries
Name 6949 0
Mara Ozolins
Address 6949 0
Centre of Evidence based dermatology, King's Meadow Campus, Lenton Lane, Nottingham, NG7 2NR
Country 6949 0
United Kingdom
Phone 6949 0
+44 115 84 68624
Fax 6949 0
+44 115 84 68618
Email 6949 0
Mara.Ozolins@Nottingham.ac.uk

No information has been provided regarding IPD availability


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Results publications and other study-related documents

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