Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT00006460
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2000-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation Therapy Plus Hyperbaric Oxygen in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-05', 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2000-11-06', 'studyFirstSubmitQcDate': '2004-02-02', 'lastUpdatePostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-02-03', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['adult glioblastoma', 'adult giant cell glioblastoma', 'adult gliosarcoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperbaric oxygen may increase the effectiveness of radiation therapy. Combining hyperbaric oxygen with radiation therapy may be an effective treatment for glioblastoma multiforme.\n\nPURPOSE: Phase I/II trial to study the effectiveness of combining radiation therapy with hyperbaric oxygen in treating patients who have newly diagnosed glioblastoma multiforme.', 'detailedDescription': 'OBJECTIVES: I. Determine the feasibility and toxicity of hyperbaric oxygen combined with conformal radiotherapy in patients with newly diagnosed glioblastoma multiforme. II. Determine the efficacy of this regimen in terms of radiographic tumor response, time to tumor progression, and survival in these patients.\n\nOUTLINE: Within 2 weeks after surgery, patients receive hyperbaric oxygen over 90 minutes once daily, followed by conformal radiotherapy twice daily 5 days a week for 17 days in the absence of unacceptable toxicity. Patients are followed within 2 weeks and then every 2 months thereafter.\n\nPROJECTED ACCRUAL: A total of 5-10 patients will be accrued for this study within 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically proven newly diagnosed glioblastoma multiforme Measurable residual tumor by MRI after biopsy or craniotomy\n\nPATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: More than 8 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: No severe pulmonary disease (e.g., emphysema with carbon dioxide retention) No untreated pneumothorax Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except epithelial skin cancer No psychological, familial, sociological, or geographical conditions that would preclude study No intractable seizure disorder\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent bleomycin Endocrine therapy: Not specified Radiotherapy: No prior cranial radiotherapy Surgery: See Disease Characteristics Other: No other prior therapy, including adjuvant therapy, for glioblastoma multiforme'}, 'identificationModule': {'nctId': 'NCT00006460', 'briefTitle': 'Radiation Therapy Plus Hyperbaric Oxygen in Treating Patients With Newly Diagnosed Glioblastoma Multiforme', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I/II Trial of Conformal Radiotherapy and Hyperbaric Oxygen for Patients With Newly Diagnosed Glioblastoma', 'orgStudyIdInfo': {'id': 'CDR0000068256'}, 'secondaryIdInfos': [{'id': 'UCMC-00021401'}, {'id': 'NCI-V00-1626'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'hyperbaric oxygen', 'type': 'DRUG'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Barrett Cancer Center, The University Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Ronald E. Warnick, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Barrett Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barrett Cancer Center', 'class': 'OTHER'}}}}