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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00066872
First received: August 6, 2003
Last updated: September 16, 2013
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Non-melanomatous Skin Cancer
Drug: imiquimod
Procedure: conventional surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Absence of local recurrence at 3 years after start of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence of basal cell cancer (BCC) at 1, 2, and 5 years [ Designated as safety issue: No ]
  • Time to first occurrence up to 5 years from completion of study treatment [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Pain at lesion site as measured by 6-point scale daily during treatment, and then 16 weeks after the completion of study treatment [ Designated as safety issue: No ]
  • Cost effectiveness assessed up to 3 or 5 years [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: October 2002
Study Completion Date: April 2010
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066872

Locations
United Kingdom
Chesterfield Royal Hospital
Chesterfield, England, United Kingdom, S44 5BL
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Solihull Hospital
Solihull, England, United Kingdom, B91 2JL
Sponsors and Collaborators
Queen's Medical Centre
Investigators
Investigator: Mara Ozolins, MS Queen's Medical Centre
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00066872     History of Changes
Other Study ID Numbers: CDR0000320513, CRUK-LON-SINS-C7484/A2869, EU-20205
Study First Received: August 6, 2003
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
basal cell carcinoma of the skin

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Skin Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on September 29, 2014