Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00003320
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation Therapy Following Surgery to Remove Brain Metastases
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-02-05', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tumors metastatic to brain'], 'conditions': ['Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery to remove brain metastases may decrease the amount of radiation required to treat brain metastases.\n\nPURPOSE: Pilot trial to study the effectiveness of radiation therapy following surgery to remove brain metastases.', 'detailedDescription': 'OBJECTIVES: I. Assess the safety and tolerability of focal stereotactic radiotherapy to the surgical bed following excision of cerebral metastases, as an alternative to whole brain irradiation. II. Measure the local relapse rate at the surgical site after surgery and stereotactic radiotherapy in patients with cerebral metastases. III. Measure the regional relapse rate, in the brain but away from the treated site, following treatment in these patients.\n\nOUTLINE: All patients undergo surgical removal of their cerebral metastases followed by adjuvant fractionated stereotactic radiotherapy daily for 5 days. Patients are given up to 5 weeks following surgery to recover and reach the required performance status. Radiotherapy must commence within 6 weeks of surgery. Patients are followed at 2 weeks after treatment, monthly for 6 months, every 3 months for the next 18 months, every 6 months for the next year, and then annually for years 3-5.\n\nPROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed cerebral metastases post surgical resection\n* No greater than 3 cerebral metastases postresection\n* Gross resection at operation as documented in operation note and postoperative MRI Patients must have current surgical sites that have not been previously irradiated\n* No other indication for whole brain irradiation (i.e., multiple untreated metastases not suitable for single fraction stereotactic radiotherapy, leptomeningeal disease)\n* Age: 18 and over\n* Karnofsky 60-100%\n* Life expectancy: At least 3 months\n* Prior or concurrent required steroids allowed\n* Prior stereotactic radiotherapy of cerebral metastases allowed provided no prior irradiation of current surgical sites\n* Prior surgery of cerebral metastases allowed\n\nExclusion Criteria:\n\n* severe asthma requiring therapy\n* allergy to iodine or contrast media\n* pregnant\n* concurrent chemotherapy\n* prior whole brain irradiation or focal irradiation to current sites of disease'}, 'identificationModule': {'nctId': 'NCT00003320', 'briefTitle': 'Radiation Therapy Following Surgery to Remove Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'Pilot Study of Adjuvant Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases', 'orgStudyIdInfo': {'id': 'CDR0000066270'}, 'secondaryIdInfos': [{'id': 'UCLA-HSPC-970101503'}, {'id': 'UCLA-HSPC-970101502'}, {'id': 'NCI-G98-1416'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'surgical procedure', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}, {'name': 'stereotactic radiosurgery', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Judith M. Ford, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}