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Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer Clinical research trials and Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer. Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer  Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
For Condition: basal cell carcinoma of the skin
Status: Recruiting
Sponsor(s): Cancer Research UK ,
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of topical imiquimod with that of surgery in treating patients who have basal cell skin cancer.
Details: 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 (patients with nodular lesions only) weeks, every 6 months for 1 year, annually for 2 years, and then at 5 years. PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaraOzolins, Study Chair, Queen's Medical Centre
Chesterfield Royal Hospital *Recruiting*
Chesterfield, England, S44 5BL
United Kingdom
Recruiting Graham Colver 44-124-627-7271
Solihull Hospital *Recruiting*
Solihull, England, B91 2JL
United Kingdom
Recruiting Irshad Zaki 44-121-424-2000
Queen's Medical Centre *Recruiting*
Nottingham, England, NG7 2UH
United Kingdom
Recruiting Hywel Williams 44-115-924-9924
Additional Information:
Study ID Numbers: CDR0000320513; CRUK-LON-SINS-C7484/A2869,EU-20205
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066872
Other Basal Cell Carcinoma Of The Skin Studies:
1. Celecoxib in Preventing Skin Cancer
2. Acitretin in Treating Patients With Skin Disease or Skin Cancer
3. Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
4. Green Tea Extract in Treating Patients With Actinic Keratosis
5. Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
Related Studies:
Other basal cell carcinoma of the skin Clinical Trials
Other England Clinical Trials
Other Solihull Clinical Trials
Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
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