Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 12:15 PM
Study NCT ID:
NCT00006456
Status:
COMPLETED
Last Update Posted:
2010-02-24
First Post:
2000-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-23', 'studyFirstSubmitDate': '2000-11-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific', 'lung metastases', 'liver metastases'], 'conditions': ['Metastatic Cancer', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Stereotactic radiosurgery delivers x-rays directly to the tumor and may cause less damage to normal tissue.\n\nPURPOSE: Phase II trial to study the effectiveness of stereotactic radiosurgery in treating patients who have liver metastases, lung metastases, or other advanced solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility of fractionated stereotactic body radiosurgery in patients with advanced extracranial tumors.\n* Assess the toxicities of this treatment regimen in these patients.\n* Determine tumor response and cause of death in these patients treated with this regimen.\n\nOUTLINE: Patients receive fractionated stereotactic body radiosurgery over 30 minutes for 5-10 days for a total of 3 treatments.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 10-25 patients will be accrued within 2-3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed malignancy\n\n * Extracranial recurrent or metastatic disease or primary tumor not predicted to be controlled with standard radiotherapy\n * Incurable with any standard therapy\n* No tumors involving critical structures (e.g., mucosal surfaces (bowel or bladder) or heart)\n* Tumor visible by CT scan\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Bilirubin less than 2.0 times upper limit of normal (ULN)\n* AST and ALT less than 5 times ULN\n\nRenal:\n\n* Creatinine less than 2.0 mg/dL\n\nPulmonary:\n\n* FEV1 greater than 0.75 L\n\nOther:\n\n* No unsuitable size or geometric proportion that would preclude stereotactic immobilization\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 14 days since prior anticancer biologic therapy and recovered\n\nChemotherapy:\n\n* At least 14 days since prior anticancer chemotherapy and recovered\n\nEndocrine therapy:\n\n* At least 14 days since prior anticancer endocrine therapy and recovered\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 14 days since prior anticancer radiotherapy and recovered\n\nSurgery:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00006456', 'briefTitle': 'Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors', 'orgStudyIdInfo': {'id': 'CDR0000068151'}, 'secondaryIdInfos': [{'id': 'P30CA016059', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016059', 'type': 'NIH'}, {'id': 'MCV-MCC-9812-2C'}, {'id': 'NCI-V00-1612'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'stereotactic radiosurgery', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298-0058', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Massey Cancer Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Danny Y. Song, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Massey Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Danny Song, MD', 'oldOrganization': 'Virginia Commonwealth University/Massey Cancer Center'}}}}