Status:
COMPLETED
CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial
Lead Sponsor:
VA Office of Research and Development
Conditions:
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The main purpose of this study is to see if 5-fluorouracil (5-FU) skin cream can prevent the growth of new skin cancers on the face and ears. The cost of trying to prevent skin cancer will be compared...
Detailed Description
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 diag...
Eligibility Criteria
Inclusion
- Veteran who is at high risk for developing skin cancer defined as 2 keratinocyte carcinomas in the past 5 years, at least one of which was located on the face or ears
Exclusion
- Participants who are unable to speak English
- Participants with KC at randomization
- Participants currently using or having used field therapy for AKs on the face or ears in the past 3 years. The vast majority of these field treatments would have been with 5-FU cream. The investigators will allow recent use of therapies that are applied to individual AK lesions (e.g. cryotherapy), but not those that were used on an entire area (field) in the study treatment area Participants currently using or having used systemic 5-fluorouracil or oral capecitabine (Xeloda) within the past 3 years Participants with known allergy to sunscreen, triamcinolone and/or 5-fluorouracil.
- Exclusions 6-l0: The investigators will exclude the small proportion who get their KCs for special reasons other than ultraviolet radiation exposure (see list below), since that etiologic difference, which is associated with a prognostic difference, could be associated with a biologic difference in response to chemoprevention efforts. These will include:
- Solid organ transplant recipients, such as renal, hepatic, or cardiac transplant patients
- Individuals with genetic disorders associated with very high cancer risk such as:
- basal cell nevus syndrome
- erythrodysplasia verruciformis
- xeroderma pigmentosum
- Arsenic exposure
- PUVA (Psoralen plus UVA) treatment
- Cutaneous T-cell lymphoma
- Prior or current radiation therapy to the face and/or ears.
- Additional exclusions (12-15) are:
- Those who, in the opinion of the recruiting investigator, have very high mortality risk at randomization (less than 50% chance of surviving 4 years) due to co morbid illness such as metastatic cancer or COPD.
- For women of childbearing potential an initial pregnancy test and ongoing birth control will be required for participation.
- Patients with known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency by self report or noted in the medical record (they have increased toxicity from systemic 5-FU, although screening for this is not part of dermatologic practice and will not be part of this study).
- Patients on methotrexate (these will constitute about 1% of potentially eligible individuals) because they may have more severe reactions to topical 5-FU.
Key Trial Info
Start Date :
June 26 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2016
Estimated Enrollment :
954 Patients enrolled
Trial Details
Trial ID
NCT00847912
Start Date
June 26 2009
End Date
July 30 2016
Last Update
June 11 2021
Active Locations (13)
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1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
2
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
3
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
4
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, United States, 33744