Trial record 4 of 26 for:    "Acoustic neuroma"

Stereotactic Radiation in Vestibular Schwannoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Ramathibodi Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Putipun Puataweepong, Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT01449604
First received: October 2, 2011
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

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).


Condition Intervention Phase
Vestibular Schwannoma
Radiation: stereotactic radiotherapy
Radiation: stereotactic radiosurgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Steretotactic Radiosurgery and Hypofractionated Steretotactic Radiotherapy in the Treatment of Vestibular Schwannoma

Resource links provided by NLM:


Further study details as provided by Ramathibodi Hospital:

Primary Outcome Measures:
  • audiogram [ Time Frame: two year ] [ Designated as safety issue: Yes ]
    change from baseline audiogram at 6 months,1 year and 2 year


Secondary Outcome Measures:
  • number of participant with adverse event [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    the new number of adverse event after radiation at 6 month,1 and 2 year

  • tumor size [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    change in tumor size at 6 month, 1 year and 2 year


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: stereotactic radiosurgery
Radio surgery single fraction 12 Gy
Radiation: stereotactic radiosurgery
Radio surgery 12 Gy
Other Name: SRS
Active Comparator: stereotactic radiotherapy
Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction
Radiation: stereotactic radiotherapy
Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions
Other Name: stereotactic radiotherapy

Detailed Description:

Vestibular schwannomas (VSs) are slow-growing tumors of the myelin-forming cells that cover cranial nerve VIII.The treatment options for patients with VSs include active observation, surgical management, and radiotherapy. However, the optimal treatment choice remain controversial.

Over the past 10 years, there has been rapid progress in the application of stereotactic radiotherapy to the treatment of VSs. The stereotactic radiotherapy program includes single fraction radiosurgery (SRS) and hypofraction stereotactic radiotherapy (HSRT) are commonly used for VSs treatment. Since SRS and SRT techniques differ significantly enough to raise questions of therapeutic advantage and until now, there is no prospective, randomized study comparing the outcomes for patients treated using both radiotherapy techniques. We designed the first prospective randomized protocol to compare SRS and SRT for answer this question.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • vestibular schwannoma tumor size not more than 3 cm.

Exclusion Criteria:

  • NF 2 patient
  • underlying cerebrovascular disease
  • tumor compress and efface brain stem ( Koos 4)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449604

Sponsors and Collaborators
Ramathibodi Hospital
Investigators
Principal Investigator: Putipun Puataweepong, M.D. Ramathibodi Hospital
  More Information

No publications provided

Responsible Party: Putipun Puataweepong, Assistant professor, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT01449604     History of Changes
Other Study ID Numbers: RAMART0111
Study First Received: October 2, 2011
Last Updated: October 6, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Ramathibodi Hospital:
Stereotactic radiotherapy
SRS
SRT
vestibular schwannoma

Additional relevant MeSH terms:
Neurilemmoma
Neuroma, Acoustic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014