Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-04 @ 9:59 PM
Study NCT ID:
NCT01891318
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2013-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2013-06-26', 'studyFirstSubmitQcDate': '2013-06-28', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'Day 0', 'description': 'MTD of radiosurgery determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Phase I)'}, {'measure': 'Proportion of participants without local failure (Phase II)', 'timeFrame': 'Up to 3 years', 'description': 'Local control of brain metastases, as measured by proportion of participants without local failure (Local failure is tumor progression of the metastasis treated on the study)\n\n(Phase II)\n\nThe Kaplan-Meier method will be used.'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with distant brain failure', 'timeFrame': 'Up to 3 years', 'description': 'Rate of distant brain failure, defined as progression of brain metastases outside of the brain metastasis treated on study. The Kaplan-Meier method will be used.'}, {'measure': 'Rate of radiation necrosis/steroid dependency', 'timeFrame': 'Up to 3 years', 'description': 'Rate of radiation necrosis/steroid dependency'}, {'measure': 'Rate of salvage treatment', 'timeFrame': 'Up to 3 years', 'description': 'Number of patients that have any salvage treatment, including surgery, stereotactic radiosurgery (SRS), or whole brain radiation therapy (WBRT)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Tumors Metastatic to Brain']}, 'descriptionModule': {'briefSummary': 'This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases. (Phase I)\n\nII. To determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection. (Phase II)\n\nSECONDARY OBJECTIVES:\n\nI. To determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection.\n\nII. To estimate the rate of salvage surgery, whole brain radiation therapy (WBRT), or stereotactic radiosurgery (SRS) for participants treated with neoadjuvant radiosurgery followed by surgical resection.\n\nIII. To determine the rate of radiation necrosis/steroid dependency. IV. To determine the radiobiologic impact of neoadjuvant radiosurgery for resected brain metastases.\n\nOUTLINE: This is a phase I, dose-escalation study of radiosurgery followed by a phase II study.\n\nThe following outcomes were removed from the protocol in an amendment:\n\n* Changes in neurocognitive function as measured by the Hopkins Verbal Learning Test (HVLT), Controlled Oral Word Association (COWA) \\& Trailmaking Test B, and Trailmaking Test A\n* QOL measured by FACT-BR and EORTC-QLQ30'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies\n* Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion \\> 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS\n* Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection\n* Patient must have a Karnofsky performance score of ≥ 70\n\nExclusion Criteria:\n\n* Patient deemed medically unfit to undergo surgical resection of brain metastasis\n* Prior whole brain radiotherapy\n* Patient with contraindication for imaging with MRI\n* Inability to participate in study activities due to physical or mental limitations\n* Inability or unwillingness to return for all the required follow-up visits\n* At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm\n* Tumor located in the brainstem\n* Imaging or cytologic evidence of leptomeningeal disease'}, 'identificationModule': {'nctId': 'NCT01891318', 'briefTitle': 'Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study', 'orgStudyIdInfo': {'id': 'CASE7312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (radiosurgery, surgery)', 'description': 'Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.', 'interventionNames': ['Radiation: radiosurgery', 'Procedure: therapeutic conventional surgery', 'Procedure: quality-of-life assessment']}], 'interventions': [{'name': 'radiosurgery', 'type': 'RADIATION', 'otherNames': ['radiation surgery'], 'description': 'Undergo radiosurgery', 'armGroupLabels': ['Treatment (radiosurgery, surgery)']}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'description': 'Undergo surgical resection', 'armGroupLabels': ['Treatment (radiosurgery, surgery)']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment (radiosurgery, surgery)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erin Murphy, MD', 'role': 'CONTACT', 'email': 'TaussigResearch@ccf.org', 'phone': '866-223-8100'}, {'name': 'Erin Murphy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Erin Murphy, MD', 'role': 'CONTACT', 'email': 'TaussigResearch@ccf.org', 'phone': '1-866-223-8100'}], 'overallOfficials': [{'name': 'Erin Murphy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}