Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer

September 16, 2013 updated by: Queen's Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Chesterfield, England, United Kingdom, S44 5BL
        • Chesterfield Royal Hospital
      • Nottingham, England, United Kingdom, NG7 2UH
        • Queen's Medical Centre
      • Solihull, England, United Kingdom, B91 2JL
        • Solihull Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Absence of local recurrence at 3 years after start of treatment

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's Medical Center

Investigators

  • Mara Ozolins, MS, Queen's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 6, 2003

First Submitted That Met QC Criteria

August 6, 2003

First Posted (Estimate)

August 7, 2003

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000320513
  • CRUK-LON-SINS-C7484/A2869
  • EU-20205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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