Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-01-02 @ 9:34 AM
Study NCT ID:
NCT03212235
Status:
UNKNOWN
Last Update Posted:
2017-07-11
First Post:
2017-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypofractionated Radiation Therapy for Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-07', 'studyFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2017-07-07', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '24 months', 'description': 'From date of the start of treatment to date of death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '24 months', 'description': 'The time between the start of treatment and tumor progression or death due to any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioblastoma Multiforme']}, 'descriptionModule': {'briefSummary': 'Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma.\n* WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function.\n\nExclusion Criteria:\n\n* Prior diagnosis of cancer, unless disease free for \\> 3 years\n* Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0).\n* Specific severe, active co-morbidities\n* Tumor located in the brainstem\n* Presence of leptomeningeal carcinomatosis\n* Multicentric tumor'}, 'identificationModule': {'nctId': 'NCT03212235', 'briefTitle': 'Hypofractionated Radiation Therapy for Glioblastoma', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'Hypofractionated Radiation Therapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma', 'orgStudyIdInfo': {'id': 'Hypofractionated GBM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypofractionated radiation therapy', 'description': 'Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week.\n\nAfter a 30-days break, adjuvant temozolomide days 1-5 every 28 days for 6 cycles.', 'interventionNames': ['Radiation: Hypofractionated radiation therapy']}], 'interventions': [{'name': 'Hypofractionated radiation therapy', 'type': 'RADIATION', 'description': 'Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)', 'armGroupLabels': ['Hypofractionated radiation therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246-000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Gustavo N Marta, PhD', 'role': 'CONTACT', 'email': 'gustavo.marta@hc.fm.usp.br', 'phone': '55+11+38934538'}], 'facility': 'Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Gustavo N Marta, PhD', 'role': 'CONTACT', 'email': 'gustavo.marta@hc.fm.usp.br', 'phone': '551138934538'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist and Principal Investigator', 'investigatorFullName': 'Gustavo Nader Marta', 'investigatorAffiliation': 'Instituto do Cancer do Estado de São Paulo'}}}}