Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT04047602
Status:
TERMINATED
Last Update Posted:
2025-02-13
First Post:
2019-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kshiue@iuhealth.org', 'phone': '317 944 2524', 'title': 'Kevin Shiue, MD', 'organization': 'Indiana University Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed'}}, 'adverseEventsModule': {'timeFrame': 'Up to 28 Months', 'description': 'Adverse events reported are those that are related to the SRS treatment and are as of February 2024. Patients are still on follow-up for the study and treatment-related adverse events can still occur. Patients were considered at risk for an adverse event if they started SRS treatment. For all-cause mortality and serious adverse events, treatment attribution was not considered.', 'eventGroups': [{'id': 'EG000', 'title': 'Reduced Dose Stereotactic Radiosurgery With Immunotherapy', 'description': 'Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 7, 'seriousNumAtRisk': 18, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'seriousEvents': [{'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Symptomatic Radiation Necrosis Proportion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Dose Stereotactic Radiosurgery With Immunotherapy', 'description': 'Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'classes': [{'categories': [{'measurements': [{'value': '0.083', 'groupId': 'OG000', 'lowerLimit': '0.002', 'upperLimit': '0.385'}]}]}], 'analyses': [{'pValue': '0.234', 'groupIds': ['OG000'], 'paramType': 'Binomial Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.083', 'ciLowerLimit': '0.002', 'ciUpperLimit': '0.385', 'pValueComment': 'The p-value reported is the one-sided p-value from the exact equivalence binomial test using an alpha value of 0.05.', 'estimateComment': 'The binomial proportion 95% confidence intervals were calculated using the Clopper-Pearson (Exact) method.', 'groupDescription': 'The observed proportion of evaluable patients with symptomatic radiation necrosis was calculated and tested against a baseline 6-month symptomatic radiation necrosis rate of 16% at a type I error rate of 5% using a one-sided binomial exact test. The null hypothesis is that the observed proportion is equivalent to 16% or 0.160.', 'statisticalMethod': 'Exact Binomial Test', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The observed proportion of evaluable patients with symptomatic radiation necrosis was calculated and tested against a baseline 6-month symptomatic radiation necrosis rate of 16% at a type I error rate of 5% using a one-sided binomial exact test. The null hypothesis is that the observed proportion is equivalent to 16% or 0.160.'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The observed proportion of evaluable patients with symptomatic radiation necrosis by 6-months. Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes those patients who were evaluable for the 6-month outcomes.'}, {'type': 'SECONDARY', 'title': 'Symptomatic Radiation Necrosis Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Dose Stereotactic Radiosurgery With Immunotherapy', 'description': 'Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'classes': [{'categories': [{'measurements': [{'value': '0.913', 'groupId': 'OG000', 'lowerLimit': '0.524', 'upperLimit': '0.987'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.', 'unitOfMeasure': 'survival probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes the patients who were evaluable for the 6-month outcomes.'}, {'type': 'SECONDARY', 'title': 'Symptomatic Radiation Necrosis Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Dose Stereotactic Radiosurgery With Immunotherapy', 'description': 'Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'classes': [{'categories': [{'measurements': [{'value': '0.913', 'groupId': 'OG000', 'lowerLimit': '0.524', 'upperLimit': '0.987'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.', 'unitOfMeasure': 'survival probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes the patients who were evaluable for the 12-month outcomes.'}, {'type': 'SECONDARY', 'title': 'Symptomatic Radiation Necrosis by SRS Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gamma Knife', 'description': 'Subjects received Gamma Knife SRS.\n\nSubjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}, {'id': 'OG001', 'title': 'Linear Accelerator', 'description': 'Subjects received Linear Accelerator SRS.\n\nSubjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'classes': [{'categories': [{'measurements': [{'value': '0.875', 'groupId': 'OG000', 'lowerLimit': '0.387', 'upperLimit': '0.981'}, {'value': '1.000', 'groupId': 'OG001', 'lowerLimit': '1.000', 'upperLimit': '1.000'}]}]}], 'analyses': [{'pValue': '0.285', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across SRS groups. The null hypothesis was that the survival probabilities were equal.', 'statisticalMethod': 'Klein Method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.', 'unitOfMeasure': 'survival probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes the patients who were evaluable for the 12-month outcomes.'}, {'type': 'SECONDARY', 'title': 'Symptomatic Radiation Necrosis by Brain Metastases Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melanoma Brain Metastases', 'description': 'Subjects had melanoma brain metastases at baseline.\n\nSubjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size.'}, {'id': 'OG001', 'title': 'Non-Melanoma Brain Metastases', 'description': 'Subjects had non-melanoma brain metastases at baseline.\n\nSubjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000', 'lowerLimit': '1.000', 'upperLimit': '1.000'}, {'value': '0.900', 'groupId': 'OG001', 'lowerLimit': '0.473', 'upperLimit': '0.985'}]}]}], 'analyses': [{'pValue': '0.292', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across brain metastases groups. The null hypothesis was that the survival probabilities were equal.', 'statisticalMethod': 'Klein Method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.', 'unitOfMeasure': 'survival probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes the patients who were evaluable for the 12-month outcomes.'}, {'type': 'SECONDARY', 'title': 'Symptomatic Radiation Necrosis by Immune Checkpoint Inhibitor (ICI) Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single-Agent ICI', 'description': 'Subjects were on a single-agent ICI at baseline.\n\nSubjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}, {'id': 'OG001', 'title': 'Multi-Agent ICI', 'description': 'Subjects were on a multi-agent ICI at baseline.\n\nSubjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'classes': [{'categories': [{'measurements': [{'value': '0.889', 'groupId': 'OG000', 'lowerLimit': '0.433', 'upperLimit': '0.984'}, {'value': '1.000', 'groupId': 'OG001', 'lowerLimit': '1.000', 'upperLimit': '1.000'}]}]}], 'analyses': [{'pValue': '0.289', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across ICI groups. The null hypothesis was that the survival probabilities were equal.', 'statisticalMethod': 'Klein Method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Ppatients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.', 'unitOfMeasure': 'survival probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes the patients who were evaluable for the 12-month outcomes.'}, {'type': 'SECONDARY', 'title': 'Local Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Dose Stereotactic Radiosurgery With Immunotherapy', 'description': 'Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.', 'unitOfMeasure': 'survival probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients evaluable for 6-month outcomes.'}, {'type': 'SECONDARY', 'title': 'Local Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Dose Stereotactic Radiosurgery With Immunotherapy', 'description': 'Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'classes': [{'categories': [{'measurements': [{'value': '0.913', 'groupId': 'OG000', 'lowerLimit': '0.524', 'upperLimit': '0.987'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.', 'unitOfMeasure': 'survival probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients evaluable for 12-month outcomes.'}, {'type': 'SECONDARY', 'title': 'Local Control by SRS Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gamma Knife', 'description': 'Subjects received Gamma Knife SRS.\n\nSubjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}, {'id': 'OG001', 'title': 'Linear Accelerator', 'description': 'Subjects received Linear Accelerator SRS.\n\nSubjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '0.750', 'groupId': 'OG001', 'lowerLimit': '0.128', 'upperLimit': '0.961'}]}]}], 'analyses': [{'pValue': '0.248', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across SRS groups. The null hypothesis was that the survival probabilities were equal.', 'statisticalMethod': 'Klein Method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.', 'unitOfMeasure': 'survival probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients who were evaluable for the 12-month outcomes.'}, {'type': 'SECONDARY', 'title': 'Local Control by Brain Metastases Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melanoma Brain Metastases', 'description': 'Subjects had melanoma brain metastases at baseline.\n\nSubjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size.'}, {'id': 'OG001', 'title': 'Non-Melanoma Brain Metastases', 'description': 'Subjects had non-melanoma brain metastases at baseline.\n\nSubjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '0.900', 'groupId': 'OG001', 'lowerLimit': '0.473', 'upperLimit': '0.985'}]}]}], 'analyses': [{'pValue': '0.292', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across brain metastases groups. The null hypothesis was that the survival probabilities were equal.', 'statisticalMethod': 'Klein Method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.', 'unitOfMeasure': 'survival probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients who were evaluable for the 12-month outcomes.'}, {'type': 'SECONDARY', 'title': 'Local Control by Immune Checkpoint Inhibitor (ICI) Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single-Agent ICI', 'description': 'Subjects were on a single-agent ICI at baseline.\n\nSubjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}, {'id': 'OG001', 'title': 'Multi-Agent ICI', 'description': 'Subjects were on a multi-agent ICI at baseline.\n\nSubjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'classes': [{'categories': [{'measurements': [{'value': '0.889', 'groupId': 'OG000', 'lowerLimit': '0.433', 'upperLimit': '0.984'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}], 'analyses': [{'pValue': '0.289', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across ICI groups. The null hypothesis was that the survival probabilities were equal.', 'statisticalMethod': 'Klein Method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.', 'unitOfMeasure': 'survival probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients who were evaluable for the 12-month outcomes.'}, {'type': 'SECONDARY', 'title': 'Radiographic Radiation Necrosis Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Dose Stereotactic Radiosurgery With Immunotherapy', 'description': 'Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'classes': [{'categories': [{'measurements': [{'value': '0.818', 'groupId': 'OG000', 'lowerLimit': '0.447', 'upperLimit': '0.951'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Radiographic radiation necrosis was defined as brain imaging findings on magnetic resonance imaging (MRI), magnetic resonance (MR) perfusion, MR Spectroscopy, and/or positron emission tomography (PET) imaging consistent with radiation necrosis. This measure details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of radiographic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.', 'unitOfMeasure': 'survival probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes the patients who were evaluable for the 6-month outcomes.'}, {'type': 'SECONDARY', 'title': 'Radiographic Radiation Necrosis Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Dose Stereotactic Radiosurgery With Immunotherapy', 'description': 'Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'classes': [{'categories': [{'measurements': [{'value': '0.818', 'groupId': 'OG000', 'lowerLimit': '0.447', 'upperLimit': '0.951'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Radiographic radiation necrosis was defined as brain imaging findings on magnetic resonance imaging (MRI), magnetic resonance (MR) perfusion, MR Spectroscopy, and/or positron emission tomography (PET) imaging consistent with radiation necrosis. This measure details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of radiographic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.', 'unitOfMeasure': 'survival probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes the patients who were evaluable for the 12-month outcomes.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reduced Dose Stereotactic Radiosurgery With Immunotherapy', 'description': 'Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Reduced Dose Stereotactic Radiosurgery', 'description': 'Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment\n\nReduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.08', 'spread': '7.59', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Corticosteroid Use at Baseline', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis-Specific Graded Prognostic Assessment (ds-GPA) Median Survival at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '11.75', 'groupId': 'BG000', 'lowerLimit': '8.30', 'upperLimit': '19.38'}]}]}], 'paramType': 'MEDIAN', 'description': "ds-GPA values were calculated using brainmetgpa.com. Survival and the factors that predict survival vary by diagnosis and the molecular profile of the patient's tumor.", 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Primary Site of Initial Cancer Diagnosis', 'classes': [{'categories': [{'title': 'Adrenal Gland', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Brain', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Kidney/Renal Pelvis', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Lung', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Melanoma', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Lesions at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'groupId': 'BG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'lesions', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': "Includes the patients who started treatment and completed the required follow-up period for the study's primary outcome."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-10', 'size': 707140, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-28T09:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'trial stopped due to low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2019-08-05', 'resultsFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-04', 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic Radiation Necrosis Proportion', 'timeFrame': '6 months', 'description': 'The observed proportion of evaluable patients with symptomatic radiation necrosis by 6-months. Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis.'}], 'secondaryOutcomes': [{'measure': 'Symptomatic Radiation Necrosis Rate', 'timeFrame': '6 months', 'description': 'Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.'}, {'measure': 'Symptomatic Radiation Necrosis Rate', 'timeFrame': '12 months', 'description': 'Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.'}, {'measure': 'Symptomatic Radiation Necrosis by SRS Group', 'timeFrame': '12 months', 'description': 'Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.'}, {'measure': 'Symptomatic Radiation Necrosis by Brain Metastases Group', 'timeFrame': '12 months', 'description': 'Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.'}, {'measure': 'Symptomatic Radiation Necrosis by Immune Checkpoint Inhibitor (ICI) Group', 'timeFrame': '12 months', 'description': 'Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Ppatients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.'}, {'measure': 'Local Control', 'timeFrame': '6 months', 'description': 'Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.'}, {'measure': 'Local Control', 'timeFrame': '12 months', 'description': 'Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.'}, {'measure': 'Local Control by SRS Group', 'timeFrame': '12 months', 'description': 'Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.'}, {'measure': 'Local Control by Brain Metastases Group', 'timeFrame': '12 months', 'description': 'Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.'}, {'measure': 'Local Control by Immune Checkpoint Inhibitor (ICI) Group', 'timeFrame': '12 months', 'description': 'Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.'}, {'measure': 'Radiographic Radiation Necrosis Rate', 'timeFrame': '6 months', 'description': 'Radiographic radiation necrosis was defined as brain imaging findings on magnetic resonance imaging (MRI), magnetic resonance (MR) perfusion, MR Spectroscopy, and/or positron emission tomography (PET) imaging consistent with radiation necrosis. This measure details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of radiographic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.'}, {'measure': 'Radiographic Radiation Necrosis Rate', 'timeFrame': '12 months', 'description': 'Radiographic radiation necrosis was defined as brain imaging findings on magnetic resonance imaging (MRI), magnetic resonance (MR) perfusion, MR Spectroscopy, and/or positron emission tomography (PET) imaging consistent with radiation necrosis. This measure details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of radiographic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Radiation', 'Immune therapy', 'Stereotactic Radiosurgery'], 'conditions': ['Brain Tumor', 'Brain Metastases', 'Brain Cancer']}, 'referencesModule': {'references': [{'pmid': '32477016', 'type': 'DERIVED', 'citation': 'McClelland S 3rd, Lautenschlaeger T, Zang Y, Hanna NH, Shiue K, Kamer AP, Agrawal N, Ellsworth SG, Rhome RM, Watson GA. Radiosurgery dose reduction for brain metastases on immunotherapy (RADREMI): A prospective phase I study protocol. Rep Pract Oncol Radiother. 2020 Jul-Aug;25(4):500-506. doi: 10.1016/j.rpor.2020.04.007. Epub 2020 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the rate of radiation necrosis following treatment with immune checkpoint inhibitor (ICI) treatment and radiation therapy in subjects with metastatic brain cancer. Subjects will be treated with the standard of care immunotherapy followed by radiation therapy via stereotactic radiosurgery at a reduced dose.', 'detailedDescription': 'This is a prospective, single arm, pilot study to determine the symptomatic radiation necrosis rate at 6 months utilizing dose-reduced stereotactic radiosurgery with immunotherapy for subjects with a diagnosis of 1-10 brain metastases from MRI and tissue diagnosis of primary malignancy.\n\nPrimary end-point is 6 month symptomatic radiation necrosis, defined as a 6-month rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. Follow-up MRIs will be fused with the planning scan for this assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Brain MRI-confirmed 1-10 solid tumor brain metastases\n2. Biopsy-confirmed primary malignancy\n3. ds-GPA estimated median survival of at least 6 months, for histologies not included in the ds-GPA, publications or noted online at brainmetgpa.com, the PI will use either published or validated data or their best clinical judgment to determine the patient's expected survival\n4. Stereotactic radiosurgery candidate per treating Radiation Oncologist\n5. ≥ 18 years old at the time of informed consent\n6. Ability to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization.\n7. ALC \\> 800/ul (Ku et al., 2010)\n8. Patients currently on cytotoxic chemotherapy are eligible\n9. Patients receiving ICI up to 30 days prior to delivery of SRS are eligible\n10. Patients having undergone operative resection for metastatic brain disease within 30 days of immune checkpoint inhibitor (ICI) administration are eligible.\n\nExclusion Criteria:\n\n1. 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\n2. Patients unable to receive MRI Brain\n3. Patients with more than 10 brain metastases on MRI Brain imaging\n4. Any lesion \\> 4 centimeter maximum diameter\n5. Total volume of metastatic disease more than 30 cubic centimeters\n6. Previous whole brain radiation therapy\n7. For Cohort 1: Previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field\n8. For Cohort 2: Patients whose treatment will have a dose overlap within the target from prior treatments of 20% or greater\n9. Already receiving chronic dexamethasone (chronic = \\> 2 weeks) prior to SRS\n10. Not a radiosurgical candidate per Radiation Oncology discretion\n11. Existing autoimmune disease\n12. Patients who have an unknown primary cancer\n13. Histology not amenable for SRS (i.e. lymphoma). (Small Cell Lung Cancer IS amenable.)"}, 'identificationModule': {'nctId': 'NCT04047602', 'acronym': 'RADREMI', 'briefTitle': 'Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study', 'orgStudyIdInfo': {'id': 'RAON-IIR-IUSCC-0710'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced Dose Stereotactic Radiosurgery', 'description': 'Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment', 'interventionNames': ['Radiation: Reduced Dose SRS']}], 'interventions': [{'name': 'Reduced Dose SRS', 'type': 'RADIATION', 'description': 'Subjects will receive SRS treatment at a reduced dose based on the brain tumor size', 'armGroupLabels': ['Reduced Dose Stereotactic Radiosurgery']}]}, '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 Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Sciences', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Kevin Shiue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical Radiation Oncology', 'investigatorFullName': 'Kevin Shiue, MD', 'investigatorAffiliation': 'Indiana University'}}}}