Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT01449604
Status:
UNKNOWN
Last Update Posted:
2011-10-10
First Post:
2011-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stereotactic Radiation in Vestibular Schwannoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009464', 'term': 'Neuroma, Acoustic'}], 'ancestors': [{'id': 'D009442', 'term': 'Neurilemmoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009463', 'term': 'Neuroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-10-06', 'studyFirstSubmitDate': '2011-10-02', 'studyFirstSubmitQcDate': '2011-10-06', 'lastUpdatePostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'audiogram', 'timeFrame': 'two year', 'description': 'change from baseline audiogram at 6 months,1 year and 2 year'}], 'secondaryOutcomes': [{'measure': 'number of participant with adverse event', 'timeFrame': '2 year', 'description': 'the new number of adverse event after radiation at 6 month,1 and 2 year'}, {'measure': 'tumor size', 'timeFrame': '2 year', 'description': 'change in tumor size at 6 month, 1 year and 2 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stereotactic radiotherapy', 'SRS', 'SRT', 'vestibular schwannoma'], 'conditions': ['Vestibular Schwannoma']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nOver 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* vestibular schwannoma tumor size not more than 3 cm.\n\nExclusion Criteria:\n\n* NF 2 patient\n* underlying cerebrovascular disease\n* tumor compress and efface brain stem ( Koos 4)'}, 'identificationModule': {'nctId': 'NCT01449604', 'briefTitle': 'Stereotactic Radiation in Vestibular Schwannoma', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'Randomized Comparison of Steretotactic Radiosurgery and Hypofractionated Steretotactic Radiotherapy in the Treatment of Vestibular Schwannoma', 'orgStudyIdInfo': {'id': 'RAMART0111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'stereotactic radiosurgery', 'description': 'Radio surgery single fraction 12 Gy', 'interventionNames': ['Radiation: stereotactic radiosurgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'stereotactic radiotherapy', 'description': 'Stereotactic radiotherapy hypo fraction 18 Gy in 3 fraction', 'interventionNames': ['Radiation: stereotactic radiotherapy']}], 'interventions': [{'name': 'stereotactic radiotherapy', 'type': 'RADIATION', 'description': 'Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions', 'armGroupLabels': ['stereotactic radiotherapy']}, {'name': 'stereotactic radiosurgery', 'type': 'RADIATION', 'otherNames': ['SRS'], 'description': 'Radio surgery 12 Gy', 'armGroupLabels': ['stereotactic radiosurgery']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Putipun Puataweepong, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramathibodi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramathibodi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Putipun Puataweepong', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}