Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-03-07 @ 10:17 PM
Study NCT ID:
NCT00107367
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2005-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2005-04-05', 'studyFirstSubmitQcDate': '2005-04-05', 'lastUpdatePostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local control rate as measured by MRI with contrast at 1 year'}]}, 'conditionsModule': {'keywords': ['tumors metastatic to brain'], 'conditions': ['Metastatic Cancer']}, 'referencesModule': {'references': [{'pmid': '25614945', 'type': 'DERIVED', 'citation': 'Weil RJ, Mavinkurve GG, Chao ST, Vogelbaum MA, Suh JH, Kolar M, Toms SA. Intraoperative radiotherapy to treat newly diagnosed solitary brain metastasis: initial experience and long-term outcomes. J Neurosurg. 2015 Apr;122(4):825-32. doi: 10.3171/2014.11.JNS1449. Epub 2015 Jan 23.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.\n\nPURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the 1-year local control rate in patients undergoing resection of a solitary brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system.\n\nSecondary\n\n* Determine the survival of patients treated with this therapy.\n* Determine distant recurrence of disease in patients treated with this therapy.\n* Determine the toxicity of this therapy in these patients.\n* Determine the quality of life of patients treated with this therapy.\n\nOUTLINE: This is a nonrandomized study.\n\nPatients undergo surgical resection of a brain metastasis. Patients then undergo intraoperative radiotherapy using the INTRABEAM® system.\n\nQuality of life is assessed at baseline and then every 3 months for 2 years.\n\nPatients are followed within 48 hours after surgery, at 1 and 3 months, and then every 3 months for 2 years.\n\nPROJECTED ACCRUAL: A total of 31-62 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan\n\n * Resectable disease\n * Histological evidence of metastatic carcinoma by intraoperative pathology\n* No primary lymphoma, germ cell carcinoma, or small cell lung cancer\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No uncontrolled hypertension\n* No unstable angina pectoris\n* No uncontrolled dysrhythmias\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No serious infection\n* No other medical illness that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior temozolomide or polifeprosan 20 with carmustine implant (Gliadel® wafer) for brain metastasis\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior brain radiotherapy of any kind, including local or whole brain external beam radiotherapy, brachytherapy, or stereotactic radiosurgery\n* No concurrent external beam radiotherapy to the brain\n* Not planning adjuvant whole brain radiotherapy after study therapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* No other prior conventional or investigational local or systemic agents for brain metastasis'}, 'identificationModule': {'nctId': 'NCT00107367', 'briefTitle': 'Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis', 'orgStudyIdInfo': {'id': 'CDR0000378144'}, 'secondaryIdInfos': [{'id': 'CCF-IRB-7003'}, {'id': 'CCF-510K'}, {'id': 'CCF-K992577'}, {'id': 'CCF-CTSRC-1065'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'intraoperative radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente', 'role': 'CONTACT', 'phone': '866-223-8100'}], 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Robert Weil, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Robert Weil', 'oldOrganization': 'Cleveland Clinic Taussig Cancer Center'}}}}