A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma
| ISRCTN | ISRCTN48755084 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48755084 |
| EudraCT/CTIS number | 2004-004506-24 |
| ClinicalTrials.gov number | NCT00066872 |
| Secondary identifying numbers | 1066 |
- Submission date
- 31/03/2010
- Registration date
- 31/03/2010
- Last edited
- 18/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Mara Ozolins
Scientific
Scientific
Centre of Evidence Based Dermatology
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
Study information
| Study design | Randomised interventional multicentre treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | SINS |
| Study objectives | 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(s) | Queen's Medical Centre, Nottingham (now Nottingham Research Ethics Committee 2), 15/11/2001, ref: LREC:DE090101 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Imiquimod 5% cream |
| Primary outcome measure | 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 study start date | 19/06/2003 |
| Completion date | 23/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | Planned sample size: 500; Actual sample size: 501 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 19/06/2003 |
| Date of final enrolment | 22/02/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre of Evidence Based Dermatology
Nottingham
NG7 2NR
United Kingdom
NG7 2NR
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
University Park
Nottingham
NG7 2RD
England
United Kingdom
| Paul.Cartledge@Nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C7484/A2869; C7484/A8991)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Protocol article | protocol | 21/04/2010 | Yes | No | |
| Results article | results | 04/10/2012 | Yes | No | |
| Results article | results | 01/01/2014 | Yes | No |
Editorial Notes
18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
