CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial
Basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of the skin, both of which are
keratinocyte carcinomas (KCs), account for a half of all cancers in the United States, and
over 100,000 diagnoses per year in the VA. The standard treatment for these KCs is excision
of the lesion, and they cost the US health care system some $2.5 billion annually and about
$100 million annually in the VA. There is no proven means to prevent KCs (except perhaps for
a modest benefit of intensive daily sunscreen use). An effective prevention strategy would
dramatically change the way high-risk patients are managed and could substantially reduce
the costs of care. Our preliminary analysis indicates that the savings will be $116 per
high-risk patient and will account for a total national savings of over $11 million. These
findings imply that the study would pay for itself by the end of 4 years. We hypothesize
that topical 5-fluourouracil (5-FU) chemoprevention will prevent skin cancer surgeries and
will be cost-saving. To test this we propose a randomized controlled trial of 5-FU compared
to a vehicle control to the face and ears in a high-risk population.
In the study, 1000 veterans at high-risk of skin cancer defined as at least 2 KCs in the
prior 5 years, at least one of which was on the face or ears, will be randomized to 5-FU or
a vehicle control cream, and followed for 2 to 4 years. The primary endpoint will be surgery
for any KC on the face and ears. We will also assess the cost of care, quality of life, the
side effects associated with treatment, and the prevalence and number of actinic keratoses,
a skin cancer precursor and itself a cause of morbidity and cost. By targeting patients at
high-risk, the study focuses on high-cost patients for whom this treatment could both
improve outcomes (cancers and quality of life) and reduce costs.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
The time to diagnosis of the first Keratinocyte Carcinoma on the face or ears for which surgery is performed
Either scheduled follow-up visits (every 6 months) or at examination requested by patient
No
Martin A. Weinstock, MD
Study Chair
VA Medical Center, Providence
United States: Federal Government
562
NCT00847912
June 2009
March 2014
Name | Location |
---|---|
VA Medical Center, Durham | Durham, North Carolina 27705 |
VA Medical Center, Miami | Miami, Florida 33125 |
Edward Hines, Jr. VA Hospital | Hines, Illinois 60141-5000 |
VA Medical Center, Providence | Providence, Rhode Island 02908 |
VA Medical Center, Jamaica Plain Campus | Boston, Massachusetts 02130 |
VA Palo Alto Health Care System | Palo Alto, California 94304-1207 |
VA Eastern Colorado Health Care System, Denver | Denver, Colorado 80220 |
VA Medical Center, Minneapolis | Minneapolis, Minnesota 55417 |
VA San Diego Healthcare System, San Diego | San Diego, California 92161 |
VA Medical Center, Philadelphia | Philadelphia, Pennsylvania 19104 |
VA Medical Center, Bay Pines | Bay Pines, Florida 33708 |
Atlanta VA Medical and Rehab Center, Decatur | Decatur, Georgia 30033 |
VA Medical Center | Nashville, Tennessee 37212-2637 |