Study of Aspirin in Patients With Vestibular Schwannoma | NCT03079999

Studies
Study of Aspirin in Patients With Vestibular Schwannoma

NCT03079999

Sponsor

Massachusetts Eye and Ear Infirmary

Status

Active, not recruiting

Last Update Posted

Dec 18, 2025Actual

Enrollment

97Actual

Phase

Phase 2

Conditions

Vestibular Schwannoma
Acoustic Neuroma
Neurofibromatosis 2

Interventions

Aspirin
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
W81XWH-17-1-0644	Other Grant/Funding Number	Congressionally Directed Medical Research Program

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2018Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Feb 2029Estimated

First Submitted Date

Mar 6, 2017

First Submission Date that Met QC Criteria

Mar 9, 2017

First Posted Date

Mar 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 18, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

D. Bradley Welling, MD, PhD, Walter Augustus Lecompte Distinguished Professor Harvard Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear InfirmaryPrincipal Investigator

Lead Sponsor

Massachusetts Eye and Ear InfirmaryOTHER

Collaborators

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

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. In the Randomized Treatment Phase, patients aged 12 years or older with VSs will be identified and recruited into one of two randomized groups who receive either 1) 325 mg aspirin twice daily (81 mg aspirin twice daily for pediatric patients <50 kg); or 2) a placebo. Patients will stay on aspirin/placebo as long as there is no more than 20% increase in VS volume. At tumor progression, patients will enter the Open Label Follow Up Phase. Patients who progress on placebo will be given the option to receive unblinded aspirin and will be followed until further progression, receiving a definitive treatment (e.g, surgery or radiation), or 42 months post-baseline, whichever occurs first. Patients who progress on aspirin (either blinded or unblinded) will be taken off study drug and followed until they receive a definitive treatment (e.g., surgery or radiation) or reach 42 months post-baseline, whichever comes first.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aspirin	Experimental	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.	Drug: Aspirin
Placebo	Placebo Comparator	Patients on the placebo arm will receive blinded placebo and take it twice a day.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aspirin	Drug	Twice daily aspirin	Aspirin	Zoprin Durlaza

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival	Progression Free Survival (PFS) is the length of time from start of study treatment to tumor growth of more than 20%.	Progression, or around 3.5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Konstantina Stankovic, MD, PhD	Stanford University	Principal Investigator
D. Bradley Welling, MD, PhD	Massachusetts Eye and Ear	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Otolaryngology/HNS		Stanford	California	94304	United States
University of Miami

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009464	Neuroma, Acoustic
D016518	Neurofibromatosis 2

Ancestor Terms

ID	Term
D009442	Neurilemmoma
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D001241	Aspirin

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

Intervention Model Description

In the Randomized Treatment Phase, patients aged 12 years or older with VSs will be identified and recruited into one of two randomized groups who receive either 1) 325 mg aspirin twice daily (81 mg aspirin twice daily for pediatric patients <50 kg); or 2) a placebo. Patients will stay on aspirin/placebo as long as there is no more than 20% increase in VS volume. At tumor progression, patients will enter the Open Label Follow Up Phase. Patients who progress on placebo will receive unblinded aspirin. Patients who progress on aspirin (either blinded or unblinded) will be taken off study drug and followed. All patients will be followed for at least 3.5 years after randomization.