Clinical trial · Interventional
Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia
Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia: a Pilot Study
NCT05505539CI-TRIAL-00061001OL_5FUwithdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal Investigator no longer with university.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Leukoplakia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-fluorouracil
- description
- 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.
- interventionNames
- Drug: 5-fluorouracil
Primary outcomes (2)
- measure
- Proportion of participants s who complete 5-FU injections
- timeFrame
- Up to 6 weeks
- description
- The number of participants who completed the full course of 3 intralesional injections will be compared to the overall total of participants. If the the mucosa becomes ulcerated or participants are unable/unwilling to continue with therapy, 5FU injections will be stopped.
- measure
- Number of participants with treatment-related adverse events
- timeFrame
- Up to 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults, 18 years of age or older * Any gender, race, or ethnicity * Clinical diagnosis of oral leukoplakia and biopsy proven dysplasia (any grade) * Oral leukoplakia at least 1 cm in largest diameter * Ability to understand and willingness to sign a written informed consent document * Willingness to provide blood and tissue from diagnostic biopsies * Any smoking history is permitted Exclusion Criteria: * Pregnant or lactating women * Men and women unwilling to use contraception while on study * History of malignancy that required cytotoxic chemotherapy within the previous 3 months * Use of 5-FU (systemic or topical) within 3 months prior to study enrollment * History of allergic reaction or severe hypersensitivity to 5-FU and/or lidocaine * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
References
Publications (0)
Data not yet available
No reference posted for this study.