[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590972":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Vermont Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Systemic Therapy With Surveillance for Brain Metastases","EXPERIMENTAL","Participants with brain metastases from solid tumors will receive standard-of-care systemic therapy expected to have intracranial activity, such as immunotherapy, targeted therapy, or anti-HER2 agents. A re-evaluation brain MRI will be performed 4-8 weeks after starting therapy. If lesions are stable or responding, patients will continue on systemic therapy with MRI surveillance every 3 months. Radiation therapy may be administered only if progression is observed. All participants are managed according to this pathway, regardless of primary tumor type.",[13],"Radiation: Active Surveillance",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Active Surveillance","Following systemic therapy, participants will undergo active surveillance with brain MRI every 3 months. Radiation therapy will only be initiated if disease progression is observed on imaging, at the discretion of the treating physician.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Randall Holcombe, MD, MBA","University of Vermont Cancer Center","STUDY_DIRECTOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Christopher Anker, MD","CONTACT","1 802 656 2021","chris.anker@uvmhealth.org",[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Burlington","Vermont","05401","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-73.21207,44.47588,{"lat":44,"lon":43},[47,49],{"name":28,"role":29,"phone":48,"phoneExt":20,"email":31},"802-656-2021",{"name":28,"role":50,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Christopher Anker","Principal Investigayor","100590972","phase-2-avoiding-radiation-therapy-due-to-intracranial-response-to-chemotherapy-targeted-therapy-andor-immuno-oncology-therapy-for-brain-metastases-pilot-pragmatic-trial-100590972",false,"NCT06974370","Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and\u002For Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial","Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and\u002For Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial (ACTION-Brain Metastases: Pilot Pragmatic Trial)","ACTION-Brain","Inclusion Criteria:\n\nPathologically (histologically or cytologically) proven diagnosis of a solid tumor malignancies within 5 years prior to registration. If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest\u002Fabdomen\u002Fpelvis, PET\u002FCT, etc.) is required. These scans are considered standard-of-care (SOC) and will not be ordered for research purposes.\n\nInitiation or planning for initiation of systemic therapy to include one or more of the following categories expected to cause an intracranial response:\n\n* Brain penetrant targeted therapies (e.g. tyrosine kinase inhibitors, multikinase inhibitors, EGFR inhibitor, ALK inhibitor, BRAF\u002FMEK inhibitor)\n* Checkpoint inhibitor immunotherapy (e.g. PDL-1 inhibitors, PD1 inhibitors, CTLA-4 inhibitors)\n* HER2 antibody-drug conjugate (e.g. TDM1, TDX-D)\n* Anti-Hormone therapies for Breast Cancer\n* Cytotoxic chemotherapy alone may be started initially, but with plan for immunotherapy or eligible targeted therapy noted above before the re-evaluation MRI head\n\nAt least 1 brain metastasis that not planned for radiation therapy or surgery.\n\nAll brain metastases not planned for resection much be ≤3 cm, with no minimum size required.\n\nSystemic therapy has started within 4 weeks of MRI brain showing new or progressive disease or plan to start systemic therapy within 4 weeks of MRI brain showing new or progressive disease.\n\nAbility to obtain MRI head scans with contrast. All MRI head scans must have slice thickness ≤1.5 mm.\n\nAge ≥ 18 years\n\nKPS \\>60\n\nAbility to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\nNo use of the planned new systemic therapy meeting 2.1.2 criteria to address brain metastases within the last 6 months.\n\nPrior radiotherapy to the active brain metastases (partial or whole brain irradiation, or prophylactic cranial irradiation \\[PCI\\])\n\nPatients pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. Negative urine pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.\n\nSerious medical comorbidities that in the opinion of the investigator would prevent participation in this study.\n\nKnown leptomeningeal disease (LMD)\n\n\\-","ALL","18 Years",{"count":65,"type":66},45,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","This pilot pragmatic trial evaluates the feasibility of avoiding radiation therapy in patients with brain metastases who demonstrate an intracranial response to systemic therapy-including immunotherapy, targeted therapy, and\u002For chemotherapy. The study will prospectively enroll 45 patients, divided into two cohorts: 30 with non-small cell lung cancer (NSCLC) receiving immunotherapy, and 15 with brain metastases from other solid tumors. Eligible participants must have at least one brain metastasis not planned for radiation or surgery and must be initiating or planning to initiate a systemic therapy regimen expected to penetrate the blood-brain barrier and achieve intracranial activity.\n\nAll patients will undergo a re-evaluation brain MRI 4-8 weeks after initiating systemic therapy. If lesions are stable or regressing, patients will continue surveillance without radiation. If progression is noted, standard-of-care radiation may be administered at the discretion of the treating physician. The primary objective is to assess 6-month radiation therapy-free survival (RTFS) in NSCLC patients based on PD-L1 expression status. Secondary endpoints include intracranial progression-free survival, overall survival, radiation necrosis rate, and quality of life. This study seeks to inform future trial design and identify patients who may safely avoid brain radiation.",[72,73],"Brain Metastases, Adult","Brain Metastases From Non-small Cell Lung Cancer (NSCLC)",[75,76,77,78,79,80,81],"Brain Metastases","Radiation Therapy","NSCLC","Quality of Life","FACT-Br","NANO Scale","Pragmatic Trial","2026-05-20",{"date":84,"type":85},"2026-05-26","ACTUAL",{"date":87,"type":85},"2025-06-05",{"date":89,"type":66},"2030-12",{"name":5,"class":6},1]