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 |
| ClinicalTrials.gov (NCT) | NCT00066872 |
| Clinical Trials Information System (CTIS) | 2004-004506-24 |
| Protocol serial number | 1066 |
| Sponsor | University of Nottingham (UK) |
| Funder | Cancer Research UK (CRUK) (UK) (ref: C7484/A2869; C7484/A8991) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional multicentre treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Imiquimod 5% cream |
| Primary outcome measure(s) |
Clinical evidence of success (absence of any signs of local recurrence) at 3 years |
| Key secondary outcome measure(s) |
1. Recurrence at 1, 2 and 5 years |
| Completion date | 23/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Centre of Evidence Based Dermatology
Nottingham
NG7 2NR
United Kingdom
NG7 2NR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/10/2012 | Yes | No | |
| Results article | results | 01/01/2014 | Yes | No | |
| Protocol article | protocol | 21/04/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
Editorial Notes
18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
