Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT03398694
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With Brain Metastases
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-14', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory: Correlation of RNA biomarkers', 'timeFrame': '2 yrs', 'description': 'Correlation of RNA biomarkers with local control'}], 'primaryOutcomes': [{'measure': 'Rate of local control of any new, recurrent, or progressing tumors within the planning target volume', 'timeFrame': '6 months', 'description': 'Measured by post-treatment MRI'}], 'secondaryOutcomes': [{'measure': 'Rate of overall survival', 'timeFrame': '6 months, 1 year, and 2 years', 'description': 'Time from start of treatment to death of any cause'}, {'measure': 'Rate of in-brain progression free survival', 'timeFrame': '6 months, 1 year, and 2 years', 'description': 'Time from start of treatment to any in-brain'}, {'measure': 'Proportion of patients with distant in-brain failure (any new parenchymal lesion outside of the planning target volume)', 'timeFrame': '2 years', 'description': 'Measured by post-treatment MRI'}, {'measure': 'Proportion of patients with radiation necrosis (radiographic or biopsy-positive diagnosis of radiation necrosis)', 'timeFrame': '2 years', 'description': 'Measured by post-treatment MRI'}, {'measure': 'Proportion of patients with leptomeningeal spread (radiographic or CSF diagnosis of leptomeningeal disease)', 'timeFrame': '2 years', 'description': 'Measured by post-treatment MRI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Metastases']}, 'referencesModule': {'references': [{'pmid': '30572923', 'type': 'DERIVED', 'citation': 'Huff WX, Agrawal N, Shapiro S, Miller J, Kulwin C, Shah M, Savage JJ, Payner T, Vortmeyer A, Watson G, Dey M. Efficacy of pre-operative stereotactic radiosurgery followed by surgical resection and correlative radiobiological analysis for patients with 1-4 brain metastases: study protocol for a phase II trial. Radiat Oncol. 2018 Dec 20;13(1):252. doi: 10.1186/s13014-018-1178-8.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, single arm, phase II trial to determine the local control at 6 months utilizing pre-operative stereotactic radiosurgery followed by surgery within 1 - 4 days in subjects with a diagnosis of 1-4 brain metastases and with an indication for surgical resection of at least one brain metastasis at the discretion of a neurosurgeon.', 'detailedDescription': 'Primary Objective To evaluate 6 month in-brain local control utilizing pre-operative stereotactic radiosurgery followed by surgical resection for brain metastases.\n\nSecondary Objectives\n\n* Overall survival\n* Distant in-brain progression\n* Rate of leptomeningeal spread\n* Rate of radiation necrosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Radiographically confirmed solid tumor brain metastases\n2. Criteria for surgical resection of at least one metastasis per neurosurgeon discretion\n3. A diagnostic MRI Brain or CT Head demonstrating the presence of 1-4 solid tumor brain metastases and lesion to be resected no more than 5 cm in any direction, performed within 30 days prior to stereotactic radiosurgery. If multiple lesions are present, then the total brain metastases volume can be no more than 30 cm3 excluding the lesion to be resected.\n4. For known primary included in brainmetgpa.com, an estimated median survival no less than 6 months per brainmetgpa.com\n5. For unknown primary or known primary not included within brainmetgpa.com, an estimated median survival no less than 6 months per PI discretion Note: If patient's estimated median survival is calculated using a histology that is different than the histology demonstrated in final pathology, the patient may remain eligible for all study endpoints per PI discretion\n6. Surgical candidate per neurosurgeon discretion\n7. Surgical resection able to be performed within 1 - 4 days after radiosurgery\n8. Stereotactic radiosurgery candidate per radiation oncologist\n9. ≥ 18 years old at the time of informed consent\n10. Ability to provide written informed consent and HIPAA authorization. This will be assessed by the consenting physician using general questions to determine the patient's ability to understand the medical problem, proposed treatment, alternatives to proposed treatment, and understand the consequences of the medical choices.\n11. Platelet count \\> 100 k/cumm, Hgb \\> 7.5 gm/dL, INR \\< 1.3, ANC \\> 1.5 k/cumm\n12. Patients currently on cytotoxic chemotherapy or immunotherapy are eligible, not including anti-VEGF therapy\n13. If a patient who meets all stated eligibility criteria is enrolled on study and then discovered to be ineligible, the tissue obtained will still be deemed eligible to remain in study for evaluation.\n\nExclusion Criteria\n\n1. Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there is increased risk of fatal brain hemorrhage with surgical resection\n2. Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up\n3. Patients with more than 4 brain metastases on MRI Brain or CT Head\n4. Lesion to be resected is more than 5 cm\n5. Total volume of metastatic disease more than 30 cm3 excluding lesion to be resected\n6. Patients with leptomeningeal metastases documented by MRI or CSF evaluation\n7. Previous whole brain radiation therapy\n8. Previous radiation therapy to lesion to be resected\n9. Planned adjuvant focal therapy including additional radiation therapy to the brain\n10. Not a surgical candidate per neurosurgeon's discretion\n11. Not a radiosurgical candidate per radiation oncologist's discretion\n12. Surgery unable to be performed between 1 - 4 days after radiosurgery\n13. Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child"}, 'identificationModule': {'nctId': 'NCT03398694', 'briefTitle': 'Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'A Phase II Study Analyzing Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With 1 - 4 Brain Metastases', 'orgStudyIdInfo': {'id': 'IUSCC-0627'}, 'secondaryIdInfos': [{'id': '1707314702', 'type': 'OTHER', 'domain': 'Indiana University IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'This is a single arm study so this arm will include all eligible subjects. All subjects will have radiosurgery 1-4 days prior to surgical resection.', 'interventionNames': ['Procedure: Radiosurgery']}], 'interventions': [{'name': 'Radiosurgery', 'type': 'PROCEDURE', 'description': 'Stereotactic radiosurgery will be delivered on all patients utilizing gamma knife or linear accelerator based techniques as per RTOG-9005 dosing criteria (Section 11 Table 1) based on tumor diameter with the exception that the largest lesion diameter to be treated with 15 Gy will be 5 cm. All apparent, previously untreated brain metastases will be treated with radiosurgery at this time.\n\nRadiosurgery will be performed 1-4 days prior to surgical resection. Vital signs and MRI Brain planning scan will be performed on the day of radiosurgery prior to the procedure.', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Namita Agrawal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Radiation Oncology', 'investigatorFullName': 'Namita Agrawal', 'investigatorAffiliation': 'Indiana University'}}}}