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Completed

NCT Number: NCT00066872

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

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.

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Key information

Conditions

Non-melanomatous Skin Cancer Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chesterfield Royal Hospital, Chesterfield, England, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imiquimod

Drug

conventional surgery

Procedure

Primary outcomes

  1. Absence of local recurrence at 3 years after start of treatment

Secondary outcomes

  1. Recurrence of basal cell cancer (BCC) at 1, 2, and 5 years

  2. Time to first occurrence up to 5 years from completion of study treatment

  3. 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

  4. Pain at lesion site as measured by 6-point scale daily during treatment, and then 16 weeks after the completion of study treatment

  5. Cost effectiveness assessed up to 3 or 5 years

Sponsors and collaborators

Lead sponsor

Queen's Medical Center

Other

Registry information

Official study title

A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma

Important dates

Study start
2002
Study completion
2010
First posted
Aug 7, 2003
Registry last updated
Sep 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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