Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer - Full Text View

Sponsor:	Queen's Medical Centre
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00066872

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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:

MedlinePlus related topics: Cancer Skin Cancer Surgery

Drug Information available for: S 26308

U.S. FDA Resources

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

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

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

Locations

United Kingdom, England
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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000320513, CRUK-LON-SINS-C7484/A2869, EU-20205
Study First Received:	August 6, 2003
Last Updated:	September 12, 2009
ClinicalTrials.gov Identifier:	NCT00066872 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

basal cell carcinoma of the skin

Additional relevant MeSH terms:

Interferon Inducers
Neoplasms by Histologic Type
Immunologic Factors
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Carcinoma, Basal Cell
Imiquimod

Skin Neoplasms
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 11, 2009