Eligibility, any sex, with Carcinoma, Basal Cell or Carcinoma, Squamous Cell. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Time to Diagnosis of the First Keratinocyte Carcinoma (KC) on the Face or Ears for Which Surgery is PerformedPrimary· From randomization to last visit prior to end of study date (6/30/2013), assessed up to four years
Diagnosis of the first Primary Basil Cell Carcinoma (BCC) or primary Squamous Cell Carcinoma (SCC) on the face or ears that was removed surgically.
Group
Value
95% CI
Arm 1: 5-fluorouracil
3.37
3.21 – NA
Arm 2: Placebo, Vehicle Control
3.52
3.08 – 3.70
Hazard Ratio for Surgically Treated KCPrimary· date of randomization to last visit before end of study follow up (6/30/2013), assessed up to four years
Group
Value
95% CI
Arm 1: 5-fluorouracil
182
Arm 2: Placebo, Vehicle Control
177
Adverse events — posted to ClinicalTrials.gov
Time frame: Active monitoring of Adverse Events and Serious Adverse Events began when the participant signed the Consent Form. Adverse Event data collection ended when the participant ended study participation, and Serious Adverse Event data collection continued until 30 days after study participation ended, assessed up to four years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm 1: 5-fluorouracil
Serious: 190/468 (41%)
Deaths: —
Arm 2: Placebo
Serious: 190/464 (41%)
Deaths: —
Serious adverse events (363 terms)
Reaction
System
Arm 1: 5-fluorouracil
Arm 2: Placebo
Pneumonia
Infections and infestations
—
—
Coronary artery disease
Cardiac disorders
—
—
Atrial fibrillation
Cardiac disorders
—
—
Fall
Injury, poisoning and procedural complications
—
—
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
—
Chest pain
General disorders
—
—
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
—
—
Cardiac failure congestive
Cardiac disorders
—
—
Myocardial infarction
Cardiac disorders
—
—
Cerebrovascular accident
Nervous system disorders
—
—
Death
General disorders
—
—
Urinary tract infection
Infections and infestations
—
—
Acute myocardial infarction
Cardiac disorders
—
—
Angina unstable
Cardiac disorders
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Deep vein thrombosis
Vascular disorders
—
—
Acute coronary syndrome
Cardiac disorders
—
—
Cellulitis
Infections and infestations
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Dementia
Nervous system disorders
—
—
Transient ischaemic attack
Nervous system disorders
—
—
Renal failure acute
Renal and urinary disorders
—
—
Other adverse events (170 terms — click to expand)
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 to the usual cost of treating skin cancer. Participants are being asked to be a part of this study because the participants have been treated for two or more skin cancers within the past five (5) years. At least one of these cancers occurred on the face or ears. Having had two or more skins cancers in the past 5 years makes it likely that participants will develop additional skin cancers in the future.
Exposure to ultraviolet radiation from the sun or artificial sources such as tanning beds is a major cause of basal cell and squamous cell carcinoma of the skin. Using lotions, creams, or gels that contain sunscreens can help protect the skin from premature aging and damage that may lead to skin cancer.
The 5-FU skin cream used in this study is FDA-approved to treat some types of skin cancers and spots that might become skin cancer. However, 5-FU skin cream has never been studied to see if it can prevent skin cancer. This drug is not approved by the FDA for how it will be used in this study.
In this study, one half of the patients will use the 5-FU cream and the other half will use a skin cream that looks identical to the 5-FU cream but does not have 5-FU or any other active drug in it.
Approximately twelve VA medical centers will work together in this study. About one thousand (1000) patients will be in this study. The study is sponsored by the U.S. Department of Veterans Affairs Cooperative Studies Program.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06793917 — Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced: a Multicenter, Open-label, Randomized Phase II
· Phase 3
· recruiting
NCT06928584 — Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer
· Phase 2
· recruiting
NCT06764875 — A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treat
· Phase 3
· recruiting
NCT05314998 — Adjuvant Trial in Patients With Resected PDAC Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy
· Phase 3
· not yet recruiting
NCT06750094 — A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild
· Phase 3
· recruiting
Other recruiting trials for Carcinoma, Basal Cell
Currently open trials in the same condition.
NCT05133427 — HIFU for Treatment of Non-nodular and Recurrent BCC
· NA
· active not recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care
· Phase 1
· not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran
· NA
· not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness
· NA
· not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans
· NA
· not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 11 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00847912.