NCT00066872

Brief 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. PURPOSE: This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
6.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2009

First QC Date

August 6, 2003

Last Update Submit

September 16, 2013

Conditions

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skin

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

imiquimodDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Chesterfield Royal Hospital

Chesterfield, England, S44 5BL, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Solihull Hospital

Solihull, England, B91 2JL, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 20409337RESULT

  • Williams 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.

    PMID: 27932240DERIVED

  • Bath-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.

    PMID: 24332516DERIVED

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mara Ozolins, MS

    Queen's Medical Center

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

October 1, 2002

Study Completion

April 1, 2010

Last Updated

September 17, 2013

Record last verified: 2009-09

Locations

GB(3)