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Anti-metabolites

5-fluorouracil for Leukoplakia (OL_5FU Trial)

Phase 1
Waitlist Available
Led By Kyle Jones, DDS, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
No Placebo-Only Group

Summary

This is a single center, open-label, interventional pilot study to assess the feasibility, safety, and preliminary efficacy of intralesional 5-FU injections for the treatment of oral leukoplakia (OL).

Eligible Conditions
  • Leukoplakia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with treatment-related adverse events
Proportion of participants s who complete 5-FU injections
Secondary study objectives
Change in area of clinically visible oral leukoplakia lesions
Change in scores on the oral mucosal diseases quality of life questionnaire (COMD-QLQ)
Proportion of participants with a change in histologic grade

Side effects data

From 2013 Phase 3 trial • 1060 Patients • NCT00121992
97%
Alopecia
73%
Asthenia
71%
Nausea
55%
Stomatitis
55%
Vomiting
28%
Diarrhoea
23%
Amenorrhoea
23%
Myalgia
22%
Pain
20%
Arthralgia
20%
Conjunctivitis
19%
Nail disorder
19%
Menstruation irregular
19%
Oedema peripheral
18%
Skin disorder
17%
Abdominal pain upper
17%
Pyrexia
17%
Decreased appetite
16%
Dysgeusia
16%
Peripheral Sensory Neuropathy
14%
Hot flush
13%
Fever in absence of infection
11%
Dyspepsia
6%
Neutropenia
5%
Lacrimation increased
5%
Cough
5%
Weight increased
5%
Insomnia
5%
Affective disorder
3%
Lung disorder
3%
Peripheral motor neuropathy
3%
Back pain
3%
Bone pain
2%
Lymphoedema
2%
Erythema
2%
Arrhythmia
2%
Haemorrhoids
2%
Dyspnoea
2%
Urinary tract infection
1%
Hyperhidrosis
1%
Flatulence
1%
Febrile neutropenia
1%
Metrorrhagia
1%
Fatigue
1%
Visual impairment
1%
Chest pain
1%
Photophobia
1%
Infection
1%
Vaginal haemorrhage
1%
Vaginal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B: TAC
Arm A: FAC

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 5-fluorouracilExperimental Treatment1 Intervention
Participants will receive up to 3 intralesional 5-fluorouracil injections (0.25 mL of a 50mg/mL solution) once every 2 weeks into an oral leukoplakia lesion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5-fluorouracil
2005
Completed Phase 4
~8440

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,588 Previous Clinical Trials
14,900,917 Total Patients Enrolled
Kyle Jones, DDS, PhDPrincipal InvestigatorUniversity of California, San Francisco
~0 spots leftby Nov 2025
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