NCT01449604

Brief Summary

The purpose of this study is to determine whether stereotactic radiosurgery (SRS)and stereotactic radiotherapy (SRT)are effective in the treatment of vestibular schwannoma (VS).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 10, 2011

Status Verified

October 1, 2011

Enrollment Period

2 years

First QC Date

October 2, 2011

Last Update Submit

October 6, 2011

Conditions

Vestibular Schwannoma

Keywords

Stereotactic radiotherapySRSSRTvestibular schwannoma

Outcome Measures

Primary Outcomes (1)

  • audiogram

    change from baseline audiogram at 6 months,1 year and 2 year

    two year

Secondary Outcomes (2)

  • number of participant with adverse event

    2 year

  • tumor size

    2 year

Study Arms (2)

stereotactic radiosurgery

ACTIVE COMPARATOR

Radio surgery single fraction 12 Gy

Radiation: stereotactic radiosurgery

stereotactic radiotherapy

ACTIVE COMPARATOR

Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction

Radiation: stereotactic radiotherapy

Interventions

stereotactic radiotherapyRADIATION

Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions

stereotactic radiotherapy
stereotactic radiosurgeryRADIATION

Radio surgery 12 Gy

Also known as: SRS
stereotactic radiosurgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • vestibular schwannoma tumor size not more than 3 cm.

You may not qualify if:

  • NF 2 patient
  • underlying cerebrovascular disease
  • tumor compress and efface brain stem ( Koos 4)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neuroma, Acoustic

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Putipun Puataweepong, M.D.

    Ramathibodi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 2, 2011

First Posted

October 10, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 10, 2011

Record last verified: 2011-10