Non-melanomatous Skin CancerPhase 3NCT00066872
Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
A Phase 3 study testing imiquimod and conventional surgery in people with Non-melanomatous Skin Cancer, run by Queen's Medical Center at 3 sites in United Kingdom.
Trial summary
RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-melanomatous Skin Cancer
- What is being tested?
- imiquimod and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Oct 2002to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed primary basal cell skin carcinoma
- Nodular or superficial lesion(s)*
- Located in low-risk areas NOTE: *Any number of lesions are allowed but only 1 lesion per patient is selected for the study
- No genetic or nevoid conditions (e.g., Gorlin's syndrome)
- No morphoeic (microinfiltrative) histology
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- No bleeding disorder
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 1 month after study participation
- No allergy to any of the study interventions
- No life-threatening disease
- Must be available for study follow-up for up to 3 years
- Must have access to a telephone
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent participation in any other experimental trial
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Chesterfield Royal Hospital
Chesterfield, England, S44 5BL
Queen's Medical Centre
Nottingham, England, NG7 2UH
Solihull Hospital
Solihull, England, B91 2JL
About this study
Official title: A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer.
PURPOSE: This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.
Read the detailed description
OBJECTIVES:
- Compare the rate of local recurrence at 3 years in patients with nodular or superficial basal cell skin cancer treated with imiquimod 5% cream vs excisional surgery.
- Compare recurrence at 6 months and 1, 2, and 5 years in patients treated with these regimens.
- Compare the time to first recurrence in patients treated with these regimens.
- Compare the aesthetic appearance of lesion sites in patients treated with these regimens.
- Compare pain in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and lesion type (nodular vs superficial). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive topical imiquimod to a single lesion once daily for 6 weeks for a superficial lesion or 12 weeks for a nodular lesion. Patients with early treatment failure or recurrence are offered surgical excision.
- Arm II: Patients undergo surgical excision. Patients are followed at 6, 12, and 18 weeks, every 6 months for 1 year, annually for 2 years, and then at 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 18 months.
- Conditions
- Non-melanomatous Skin Cancer
- Being tested
- imiquimod, conventional surgery
- Keywords
- basal cell carcinoma of the skin
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imiquimodDrug
conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of local recurrence at 3 years after start of treatment
Secondary outcomes (5)
Recurrence of basal cell cancer (BCC) at 1, 2, and 5 years
Time to first occurrence up to 5 years from completion of study treatment
Aesthetic appearance of lesion site as measured by participant and blind observer using 5-point Likert scale at 6 months, and then years 1-3
Pain at lesion site as measured by 6-point scale daily during treatment, and then 16 weeks after the completion of study treatment
Cost effectiveness assessed up to 3 or 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study startOct 2002
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-melanomatous Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Mara Ozolins, MS, Queen's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066872
- Sponsor's protocol ID
- CDR0000320513
- Other IDs
- CRUK-LON-SINS-C7484/A2869, EU-20205
- Status last verified
- Sep 2009
- First submitted
- 6 Aug 2003
- Last updated
- 17 Sep 2013
- Results posted
- No
Publications
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 Apr 21;11:42. doi: 10.1186/1745-6215-11-42.
PubMed 20409337Williams HC, Bath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PSJ; Surgery Versus Imiquimod for Nodular and Superficial Basal Cell Carcinoma (SINS) Study Group. Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial. J Invest Dermatol. 2017 Mar;137(3):614-619. doi: 10.1016/j.jid.2016.10.019. Epub 2016 Dec 5.
PubMed 27932240Bath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PS, Williams HC; Surgery versus Imiquimod for Nodular Superficial basal cell carcinoma (SINS) study group. Surgical excision versus imiquimod 5% cream for nodular and superficial basal-cell carcinoma (SINS): a multicentre, non-inferiority, randomised controlled trial. Lancet Oncol. 2014 Jan;15(1):96-105. doi: 10.1016/S1470-2045(13)70530-8. Epub 2013 Dec 11.
PubMed 24332516
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00066872
- Acronym / sponsor ID
- CDR0000320513
- Conditions
- Non-melanomatous Skin Cancer
- Keywords
- basal cell carcinoma of the skin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Queen's Medical CenterUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Apr 2010 (actual)
- First posted
- 7 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer.
PURPOSE: This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.
Detailed description
OBJECTIVES:
- Compare the rate of local recurrence at 3 years in patients with nodular or superficial basal cell skin cancer treated with imiquimod 5% cream vs excisional surgery.
- Compare recurrence at 6 months and 1, 2, and 5 years in patients treated with these regimens.
- Compare the time to first recurrence in patients treated with these regimens.
- Compare the aesthetic appearance of lesion sites in patients treated with these regimens.
- Compare pain in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and lesion type (nodular vs superficial). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive topical imiquimod to a single lesion once daily for 6 weeks for a superficial lesion or 12 weeks for a nodular lesion. Patients with early treatment failure or recurrence are offered surgical excision.
- Arm II: Patients undergo surgical excision. Patients are followed at 6, 12, and 18 weeks, every 6 months for 1 year, annually for 2 years, and then at 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imiquimod | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Absence of local recurrence at 3 years after start of treatment
5 secondary outcomes
Recurrence of basal cell cancer (BCC) at 1, 2, and 5 years
Time to first occurrence up to 5 years from completion of study treatment
Aesthetic appearance of lesion site as measured by participant and blind observer using 5-point Likert scale at 6 months, and then years 1-3
Pain at lesion site as measured by 6-point scale daily during treatment, and then 16 weeks after the completion of study treatment
Cost effectiveness assessed up to 3 or 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Results publication: PubMed 20409337Ozolins 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 Apr 21;11:42. doi: 10.1186/1745-6215-11-42.
- Derived from this study: PubMed 27932240Williams HC, Bath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PSJ; Surgery Versus Imiquimod for Nodular and Superficial Basal Cell Carcinoma (SINS) Study Group. Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial. J Invest Dermatol. 2017 Mar;137(3):614-619. doi: 10.1016/j.jid.2016.10.019. Epub 2016 Dec 5.
- Derived from this study: PubMed 24332516Bath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PS, Williams HC; Surgery versus Imiquimod for Nodular Superficial basal cell carcinoma (SINS) study group. Surgical excision versus imiquimod 5% cream for nodular and superficial basal-cell carcinoma (SINS): a multicentre, non-inferiority, randomised controlled trial. Lancet Oncol. 2014 Jan;15(1):96-105. doi: 10.1016/S1470-2045(13)70530-8. Epub 2013 Dec 11.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mara Ozolins, MS
Queen's Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing imiquimod and conventional surgery in people with Non-melanomatous Skin Cancer, run by Queen's Medical Center at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of local recurrence at 3 years after start of treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00066872, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.