Clinical trial · Interventional
Study of Aspirin in Patients With Vestibular Schwannoma
Prospective, Randomized, Placebo-Controlled Phase II Trial of Aspirin for Vestibular Schwannomas
NCT03079999CI-TRIAL-00099238active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase II prospective, randomized, double-blind, longitudinal study evaluating whether the administration of aspirin can delay or slow tumor growth and maintain or improve hearing in VS patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acoustic Neuroma | Vestibular Schwannoma | ALIAS | 0.90 |
| Neurofibromatosis 2 | — | UNRESOLVED | — |
| Vestibular Schwannoma | Vestibular Schwannoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin | Drug | Aspirin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aspirin
- description
- Patients on the experimental arm will receive blinded aspirin. Pediatric subjects who weigh less than 110 lbs will take 81mg aspirin twice a day. All other subjects will take 325mg aspirin twice a day.
- interventionNames
- Drug: Aspirin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients on the placebo arm will receive blinded placebo and take it twice a day.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Radiographic diagnosis of vestibular schwannoma (NF2-associated or sporadic). * Age≥12 years. * Ability to provide informed consent.Pediatric patients must provide assent in addition to their parents'/guardians' consent. Adult patients who cannot consent for themselves will not be eligible to participate in this study. * Ability to swallow tablets. Exclusion Criteria: * Inability to perform volumetric measurements of vestibular schwannoma(s). * Inability to tolerate MRI with contrast. * Daily use of aspirin within the last two months. Occasional use of aspirin for pain relief is not exclusionary. * Known allergy to aspirin. * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of aspirin. * Pregnant or lactating women. * Patients with serious medical illnesses (e.g. severe asthma) that in the option of the investigator could prevent participation in the trial. * Active bleeding diathesis. * Hydrocephalus from brainstem compression. * Febrile illness or flu-like illness in children and adolescents less than 18 years of age.
References
Publications (0)
Data not yet available
No reference posted for this study.