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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003611 |
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of acitretin may be an effective way to prevent the recurrence or further development of skin cancer.
PURPOSE: Randomized clinical trial to study the effectiveness of acitretin in preventing skin cancers in patients with at least two previously treated skin cancers who have undergone organ transplantation.
Condition | Intervention |
Non-Melanomatous Skin Cancer |
Drug: acitretin |
MedlinePlus related topics: | Cancer Skin Cancer |
ChemIDplus related topics: | Acitretin |
Study Type: | Interventional |
Study Design: | Prevention, Randomized |
Official Title: | Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers |
Estimated Enrollment: | 110 |
Study Start Date: | May 2000 |
Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to age (at least 18 to under 50 vs 50 to 59 vs 60 to 69 vs 70 and over), number of prior skin cancers in past 5 years (2 vs 3 vs at least 4), time since most recent skin cancer occurrence (less than 12 months vs at least 12 months), sunburn susceptibility (none vs moderate vs high), visible skin damage (mild vs moderate vs severe).
Patients receive either oral acitretin or placebo daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 4-5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least 2 prior (same event or separate events) basal cell carcinomas (BCC) or squamous cell carcinomas (SCC) resected
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Arizona | |||||
CCOP - Scottsdale Oncology Program | |||||
Scottsdale, Arizona, United States, 85259-5404 | |||||
United States, Florida | |||||
Mayo Clinic | |||||
Jacksonville, Florida, United States, 32224 | |||||
United States, Illinois | |||||
CCOP - Carle Cancer Center | |||||
Urbana, Illinois, United States, 61801 | |||||
CCOP - Illinois Oncology Research Association | |||||
Peoria, Illinois, United States, 61602 | |||||
United States, Iowa | |||||
CCOP - Iowa Oncology Research Association | |||||
Des Moines, Iowa, United States, 50309-1016 | |||||
United States, Kansas | |||||
CCOP - Wichita | |||||
Wichita, Kansas, United States, 67214-3882 | |||||
United States, Minnesota | |||||
CentraCare Health Plaza | |||||
Saint Cloud, Minnesota, United States, 56303 | |||||
Mayo Clinic Cancer Center | |||||
Rochester, Minnesota, United States, 55905 | |||||
United States, North Dakota | |||||
Medcenter One Health System | |||||
Bismarck, North Dakota, United States, 58501 | |||||
United States, South Dakota | |||||
CCOP - Sioux Community Cancer Consortium | |||||
Sioux Falls, South Dakota, United States, 57104 | |||||
Rapid City Regional Hospital | |||||
Rapid City, South Dakota, United States, 57709 |
North Central Cancer Treatment Group |
National Cancer Institute (NCI) |
Study Chair: | Mark R. Pittelkow, MD | Mayo Clinic |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000066688, NCCTG-969251, NCI-P98-0137 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003611 |
Health Authority: | United States: Federal Government |
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