[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-metastases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-metastases":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,84,0,25,[9,41,65,89,120,192,227,260,282,306,326,351,375,401,427,451,474,500,524,552,572,593,610,628,655],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100239086","phase-1-stereotactic-radiosurgery-dose-escalation-for-brain-metastases-100239086",false,"NCT02390518","Stereotactic Radiosurgery Dose Escalation for Brain Metastases","Phase I Study of Stereotactic Radiosurgery Dose Escalation for Brain Metastases","Inclusion Criteria:\n\n* Clinically confirmed brain metastases by CT or MRI criteria. If there is evidence of extra-cranial metastatic disease, it is preferable that the lesions be pathologically confirmed (see section 4.2.5 for excluded histologies) and reviewed by a University of Utah or Huntsman Cancer Hospital pathologist if the initial review was done at an outside facility.\n* Prior brain surgery is allowed, although a lesion situated in the operative bed would not be selected to receive an experimental dose of SRS treatment. SRS should be delivered 4-6 weeks post-surgery if the patient had a craniotomy for resection of a lesion. Enrollment of a patient with the goal of performing SRS outside of the 4-6 post-craniotomy window is at the PI's discretion.\n* Patients must have 1-5 untreated brain metastases total.\n* For patients planning to enroll in Cohort 1a (including expansion) or Cohort 1b: Tumor volume ≤ 4.1888 cm3 by CT or MRI measurement at the time of consultation\u002Fscreening for the metastatic lesion on trial. Patients who have at least one additional lesion that is larger than the lesions eligible for the expansion cohort, but who are unable to find another open cohort, will have the eligible lesion(s) treated in the expansion cohort, and the remaining lesion(s) treated at the standard dose.\n\n  * For patients enrolling in the expansion Cohort 1a: Up to five brain metastases with tumor volume ≤ 0.5237 cm3 by CT or MRI measurement at the time of consultation\u002Fscreening will be treated on trial with the MTD. Brain metastases with volume \\> 0.5237 cm3 will be treated by standard of care SRS dosing.\n  * For patients enrolling in Cohort 1b: Tumor volume of \\> 0.5237 cm3 and ≤ 4.1888 cm3 by CT or MRI measurement at the time of consultation\u002Fscreening for the metastatic lesion on trial. All other brain metastases will be treated by standard of care SRS dosing.\n* As of Protocol Version 9, Cohorts 2 and 3 are permanently closed to accrual. For patients planning to enroll in Cohort 2 or 3: Equivalent tumor diameter ≤ 40 mm by CT or MRI measurement at the time of consultation\u002Fscreening for the metastatic lesion on trial. Equivalent tumor diameter \\\u003C\u002F=40 mm by CT or MRI measurement for all lesions treated by standard of care SRS dosing.\n* All metastatic lesions must be separated by a minimum of 3 cm as measured from the peripheral edges of the lesions that are in closest proximity to one another. If multiple lesions are present and are not all ≥ 3 cm away from each other, the patient will be deemed ineligible.\n* Prior systemic therapy is allowed, although appropriate washout is required for patients who have been on BRAF inhibitors (at least 7 days).\n* For subjects currently on active systemic cancer therapy, the treating medical oncologist should be consulted to ensure proper washout (if appropriate) periods prior to SRS.\n* Patients must be at least 18 years of age.\n* Karnofsky Performance Status (KPS) ≥ 60.\n* Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.\n* Women of child-bearing potential must have a negative pregnancy test within 10 days of study enrollment and must agree to use an acceptable method of birth control while receiving radiation and for 3 months after radiation. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for \\>1 year.\n* Men who are able to father a child must agree to use an acceptable method of birth control while receiving radiation, and for 3 months after radiation.\n\nExclusion Criteria:\n\n* Prior whole brain irradiation.\n* Brain lesions with an equivalent diameter of \\> 40 mm in size on MRI imaging at the time of consultation\u002Fscreening for protocol eligibility.\n* Lesions located in anatomic regions that are not amendable to SRS (e.g., optic nerve)\n* Brain lesions located in the brain stem.\n* Radiographic or cytologic evidence of leptomeningeal disease\n* Primary lesion with radiosensitive histology that includes the following: small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma\n* Women of child-bearing potential who are pregnant or breast feeding\n* Patients with multiple lesions, which by size criteria would be enrolled in a cohort that is full at the time of enrollment and the 12-16 weeks DLT period has not yet been reached.","ALL","18 Years",{"count":20,"type":21},86,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a Phase I dose escalation and expansion trial. The purpose of this study is to determine the maximum tolerated dose of radiation received during stereotactic radiosurgery in patients with brain metastases who have never received radiation to the brain before.",[27],"Brain Metastases","RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":32},"2015-05-07",{"date":36,"type":21},"2029-10",{"name":38,"class":39},"University of Utah","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100563762","phase-2-ex-vivo-drug-response-evaluation-for-next-generation-care-of-brain-metastases-100563762","NCT06620380","Ex Vivo Drug Response Evaluation for Next Generation Care of Brain Metastases","EViDENCE-BM","Inclusion Criteria:\n\n* Patients must be 18 years or older on the day of signing the informed consent, female or male.\n* Patients must have a Karnofsky performance status of 60 or more\n* Patients must have limited systemic therapeutic options as per treating physician judgement. The number of previous lines of therapies is not limited.\n* Patients with a tumor with a targetable oncogenic driver mutation should have already been treated with a targeted agent and options must have been exhausted.\n* Patients must have a clinical indication for surgery for probable brain metastasis\n* Patients will be considered eligible for the study only if the diagnosis of brain metastasis has been histologically confirmed on the sample obtained during the surgery performed after signing the informed consent form for the trial.\n* Any type of primary cancer is allowed: breast cancer, lung cancer, melanoma, other cancers. Patients may have several primary cancers.\n* Patients must have adequate bone marrow, renal and hepatic function documented at screening before surgery\n* Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test\n* Patients must have the ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.\n* Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.\n\nExclusion Criteria:\n\n* Patients with rapidly progressive systemic disease\n* Patients with inability to undergo brain MRI evaluation.\n* Patients with progressive parenchymal brain metastases with an indication for requiring whole brain radiotherapy after surgery. Focal brain radiotherapy after surgery is allowed.\n* Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.\n* Intention to become pregnant during the course of the study.\n* Female who are pregnant.\n* Female who are breastfeeding and who do not agree to discontinue nursing prior to the first treatment initiated during the study.\n* Sexually active males and females of childbearing potential who are not willing to use an effective contraceptive method during the study. Male participants who do not agree not to donate sperm.",{"count":49,"type":21},102,[51],"PHASE2","Pharmacoscopy refers to an ex vivo real-time drug sensitivity profiling platform that has been shown to be of value in the treatment of leukemia (Snijder et al. 2017) (Kornauth et al. 2022) and may help to identify novel treatment opportunities for brain tumors as well (Lee et al. 2022). The rationale for pharmacoscopy-based drug sensitivity testing on real-time patient biopsies or surgery material is multiple: measuring drug response and sensitivity directly in real-time patient material, overcomes the problem of limited molecular biomarkers for established targeted therapeutic options and can identify effective drugs even for non-targeted therapies such as chemotherapy. It can also identify hitherto unknown specific vulnerabilities of cancer cells. Furthermore, testing directly on patient material overcomes the limitations of patient-derived cell cultures, organoids, and patient xenografts, as their prolonged culture times risk cellular adaptations and clonal selection that alter drug sensitivity. Pharmacoscopy maintains the tumor cell composition, including bystander cells or tumor microenvironment, and limits cell culture to max 48 hours. Furthermore, pharmacoscopy measures drug responses on a single-cell and on a high-content level, uniquely allowing to measure the drug sensitivity of tumor cells, and allowing to compare it to the drug cytotoxicity on healthy cells from the same patient. This relative readout has previously been shown to be essential for the correct prediction of a clinical response in haematological malignancies (Snijder et al. 2017) (Kornauth et al. 2022).\n\nThe aim of this study is to generate preliminary data regarding superiority of the personalized pharmacoscopy-guided approach compared to a standard non-pharmacoscopy-guided approach, in patients with brain metastases with an indication for surgery, and limited therapeutic systemic options according to the treating physician.",[27,54],"Brain Metastases, Adult","2026-06-25",{"date":57,"type":32},"2026-06-29",{"date":59,"type":32},"2025-09-12",{"date":61,"type":21},"2027-06",{"name":63,"class":39},"University of Zurich",3,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":40},"100612026","phase-2-memory-avoidance-whole-brain-radiotherapy-vs-hippocampal-avoidance-whole-brain-radiotherapy-athena-2-trial-100612026","NCT07248228","Memory Avoidance Whole Brain Radiotherapy vs Hippocampal Avoidance Whole Brain Radiotherapy (Athena 2 Trial)","A Randomized Phase 2 Trial of Memory Avoidance Whole Brain Radiotherapy Versus Hippocampal Avoidance Whole Brain Radiotherapy (Athena 2 Trial)","Inclusion Criteria:\n\n* Participants must have histologically, cytologically, or radiographically confirmed diagnosis of solid tumor with brain metastases\n* Age \\>18 years\n* Performance status: Karnofsky Performance Status (KPS) ≥ 70\n* Estimated life expectancy of at least 3 months\n* Participant must be considered a candidate for WBRT by the treating physician\n* Participant must be a primary English speaker and have the ability to understand and the willingness to sign an English written informed consent document\n* Participant has at least 10 brain metastases or is otherwise suitable for WBRT\n\nExclusion Criteria:\n\n* Prior whole brain radiation\n* Participant has Multiple Sclerosis, Alzheimer's, dementia, or mental disability\n* Pregnant or breastfeeding women are excluded from this study.\n* Participant is not able to receive an MRI\n* Participant has metastasis within avoidance neurocognitive substructures (hippocampus, amygdala, fornix, corpus callosum, pituitary, amygdala)",{"count":73,"type":21},90,[51],"Participants in this research study have cancer that has spread to their brain, called brain metastases. One treatment for this type of cancer is called whole brain radiotherapy that stays away from a specific neurocognitive substructure, called the hippocampus, combined with medication to preserve cognitive function. This study compares that approach to another approach of whole brain radiotherapy that stays away from additional structures that are thought to have a role in cognitive function. Researchers want to see if there is a difference in the preservation of cognitive function between these two approaches.",[27],[78,79,80],"Whole brain radiotherapy","Memory-avoidance whole brain radiotherapy","Hippocampal-avoidance whole brain radiotherapy","2026-06-23",{"date":55,"type":32},{"date":84,"type":21},"2026-07",{"date":86,"type":21},"2028-11",{"name":88,"class":39},"Case Comprehensive Cancer Center",{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":119},"100448857","remaster-recurrent-brain-metastases-after-srs-trial-100448857","NCT05124912","REMASTer: REcurrent Brain Metastases After SRS Trial","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Patients with radiographically proven (by gadolinium-enhanced \\[Gd-\\] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer.\n2. Patients with a \"targetable\", bidimensionally-measurable, intracranial lesion that is radiographically recurrent after previous treatment with SRS +\u002F- surgery (craniotomy or LITT). To classify a lesion as radiographically progressive, the lesion must demonstrate a ≥ 25% increase in size following treatment based on the Neuro-Oncology Criteria of Tumor Response for CNS Tumors. To be \"targetable\" for this study, the lesion should be coverable through a planned single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm. An intra-operative decision to utilize two trajectories is acceptable and patient may remain on study.\n3. Patient must be at least 3 months post initial SRS treatment of the target lesion\n4. Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon.\n5. Frozen pathology diagnosis must be attainable.\n6. Patient must be symptomatically stable for a minimum of 3 days prior to the procedure date on a on a max total daily steroid dose equivalent to 4mg of Dexamethasone.\n7. ≥18 years of age\n8. KPS ≥70\n9. Patient is able and willing to complete study requirements\n10. Patients with adequate hematologic parameters (all tests to be performed within \\\u003C4 weeks of biopsy):\n\n    1. ANC ≥ 1.5 X 109\u002FL\n    2. Platelet count ≥ 100 x 109\u002FL\n11. Blood chemistry laboratory value for serum creatinine \\\u003C 1.5 x ULN (test to be performed within \\\u003C4 weeks of biopsy)\n12. Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and\u002For hysterectomy or to those patients who are postmenopausal)\n13. All patients of reproductive potential must agree to use an effective method of contraception during the study\n14. Patients must be accessible for follow-up\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Patients with greater than 3 progressing lesions at time of enrollment. To classify as a radiographically progressive, lesion must demonstrate a ≥ 25% increase in size following treatment based on the RANO criteria. Of note, there is no exclusion for total number of metastases. However, only one lesion can be selected to be the targeted lesion and this lesion alone may be ablated during the study procedure.\n2. Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will require prioritized and different treatment approaches.\n3. Prior bevacizumab use within 4 weeks of study initiation\n4. Patients with additional concurrent malignancies requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix\n5. Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to complete the protocol related QOL questionnaires and cognition assessments\n6. Inability to tolerate or contraindication to steroid therapy (i.e., dexamethasone)\n7. Deemed ineligible or unable to tolerate SRS therapy by treating neurosurgeon and\u002For radiation oncologist\n8. Patients with any condition that would prohibit them from undergoing a surgical procedure, at the discretion of the treating physician team\n9. Patients unwilling or unable to give consent for participation\n10. Patients unable to comply with study requirements\n11. Patients with diffuse leptomeningeal disease\n12. Patients with rapidly progressing extracranial disease",{"count":96,"type":21},261,[98],"NA","Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.",[27,101,102,103],"Radiation Necrosis","Recurrent Tumor","Recurrent Metastases",[105,106,107,108,101,27],"Laser Interstitial Thermal Therapy","Stereotactic Radiosurgry","LITT","SRS","2026-06-17",{"date":111,"type":32},"2026-06-18",{"date":113,"type":32},"2022-05-10",{"date":115,"type":21},"2028-10",{"name":117,"class":118},"Monteris Medical","INDUSTRY",9,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":163,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":191},"100499720","phase-1-phase-12-trial-of-s241656-in-selected-rasmapk-mutation--positive-malignancies-100499720","NCT05786924","Phase 1\u002F2 Trial of S241656 in Selected RAS\u002FMAPK Mutation- Positive Malignancies","A Phase 1\u002F2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS\u002FMAPK Mutation-Positive Malignancies","Key Inclusion Criteria:\n\n* Life expectancy of ≥ 12 weeks in the opinion of the investigator.\n* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.\n* Adequate bone marrow and organ function.\n* Recovered from toxicity to prior anti-cancer therapy.\n\nPart 1 Dose Escalation cohort ONLY:\n\n* Part 1A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations\n* Part 1B: Advanced\u002Fmetastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1C: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1E: Other advanced\u002Fmetastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations\n\nPart 2 Dose Optimization and Expansion cohorts ONLY:\n\n* Part 2A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations and\u002For BRAF mutations\n* Part 2A1: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations\n* Part 2A2: Advanced\u002Fmetastatic NSCLC with BRAF mutations\n* Part 2A3: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease\n* Part 2A4: Advanced\u002Fmetastatic NSCLC with a KRAS G12C mutation\n* Part 2B1: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B2: Advanced\u002Fmetastatic CRC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B3: Advanced\u002Fmetastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n\nKey Exclusion Criteria:\n\n* Cancer that has a known MEK1\u002F2 mutation.\n* Known allergy\u002Fhypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.\n* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.\n* Major surgery within 4 weeks of study entry or planned during study.\n* Ongoing anticancer therapy.\n* Ongoing radiation therapy.\n* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.\n* Clinically significant cardiovascular disease.\n* Symptomatic spinal cord compression.\n* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.\n* Females who are pregnant or breastfeeding.\n* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.\n* Prior use of experimental agents that target the KRAS\u002FBRAF\u002FMEK\u002FERK pathway.",{"count":128,"type":21},554,[24,51],"BDTX-4933-101 is a first-in-human, open-label, Phase 1\u002F2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced\u002Fmetastatic NSCLC with KRAS and\u002For BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.",[132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,27,156,157,158,159,160,161,162],"Non-small Cell Lung Cancer","Histiocytic Neoplasm","Histiocytosis","BRAF Gene Mutation","BRAF V600E","BRAF V600 Mutation","BRAF Mutation-Related Tumors","BRAF","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Lung Cancer","Recurrent Lung Cancer","Recurrent Lung Non-Small Cell Carcinoma","NSCLC","Solid Tumor","Solid Carcinoma","KRAS G12D","KRAS G12V","KRAS Mutation-Related Tumors","NRAS Gene Mutation","Thyroid Cancer","Thyroid Carcinoma","Colorectal Cancer","Colorectal Carcinoma","Recurrent Histiocytic and Dendritic Cell Neoplasm","Recurrent NSCLC","KRAS G13C","Acquired Resistance to KRAS G12C Inhibitor","KRAS G12A","KRAS G12F","KRAS G12R","KRAS G13D",[164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182],"BRAF Class I","BRAF Class II","BRAF Class III","KRAS","Intolerant histiocytic neoplasm","BDTX-4933","Phase 1","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAS","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","NRAS","RAF fusions","2026-06-16",{"date":109,"type":32},{"date":186,"type":32},"2023-04-18",{"date":188,"type":21},"2028-06",{"name":190,"class":39},"Institut de Recherches Internationales Servier",27,{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":217,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100431578","phase-2-stereotactic-brain-directed-radiation-with-or-without-aguix-gadolinium-based-nanoparticles-in-brain-metastases-100431578","NCT04899908","Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases","A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone","Inclusion Criteria:\n\n* Participants must have a biopsy proven solid malignancy and at least one intracranial measurable lesion spanning ≥5mm in maximal unidimensional size and radiographically consistent with or pathologically proven to be a brain metastasis AND meet one of the following additional criteria regarding the primary site or nature of the intracranial disease:\n\n  * Melanoma with intracranial growth consistent with tumor progression despite immunotherapy\n  * Gastrointestinal primary\n  * HER2 positive breast cancer (subtype assessed using most representative tissue available in opinion of enrolling clinician and\u002For study PI)\n  * Cystic metastases\n  * Metastases ≥2cm in maximal unidimensional size\n  * Locally recurrent metastases after prior stereotactic radiation\n  * Locally recurrent metastases after prior whole brain radiation \\*Patients with metastases from melanoma, GI primaries, or HER2+ breast cancer, as well as those with cystic metastases or metastases ≥2cm in maximal unidimensional size, who have local recurrences after prior brain-directed radiation can only be treated in the strata permitting prior radiation (last two strata above)\n* Age ≥18 years at diagnosis of brain metastases\n* Estimated glomerular filtration rate of ≥ 60 mL\u002Fmin\u002F1.73m2\n* Karnofsky performance status of at least 70 (i.e. at minimum, \"cares for self\" but \"unable to carry on normal activity or do active work\")\n* Estimated survival based on extracranial disease of at least 3 months in the opinion of the enrolling clinician and\u002For study PI\n* Ability to understand and the willingness to sign a written informed consent document\n* The effects of AGuIX on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the therapeutic component of study participation\n\nExclusion Criteria:\n\n* Participants who cannot undergo a brain MRI\n* Participants who cannot receive gadolinium\n* Participants with widespread, definitive leptomeningeal disease\n* Patients requiring radiation to either \\>10 targets (if naïve to whole brain radiation) or \\>20 targets (if whole brain radiation has been given previously) per the discretion of the treating clinician and\u002For study PI\n* Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study\n* In cohorts who have received prior brain-directed radiation, patients are not eligible for this study if they have active (at the time of protocol screening) brain metastases that require radiation that are in or within 1.0cm of the brainstem, eyes, optic nerves, or optic chiasm if the juxtaposed organ at risk (i.e. brainstem, eyes, optic nerves, or optic chiasm) has previously received either \\>6.0 Gy in a single fraction or, if prior radiation was fractionated, a cumulative dose in 2.0 Gy equivalents, using an alpha\u002Fbeta ratio of 2, of \\>40.0 Gy. In addition, all patients who have had prior brain-directed radiation, regardless of technique\u002Fdose\u002Ffractionation, are not eligible for the study until written approval is provided by the study\u002Fsite PI",{"count":200,"type":21},134,[51],"The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that are more difficult to control with stereotactic radiation alone.",[204,27,205,206,207,208,153,209,108,210,211,212,213,214,215,216],"Brain Cancer","Melanoma","Lung Cancer","Breast Cancer","HER2-positive Breast Cancer","Gastrointestinal Cancer","SRT","Whole Brain Radiation","Stereotactic Radiation","AGuIX","Nanoparticle","Cystic","Brain Tumor",[204,27,205,206,207,208,153,209,108,210,218,212,213,214,215,216],"Whole brain radiation",{"date":109,"type":32},{"date":221,"type":32},"2021-09-15",{"date":223,"type":21},"2029-05",{"name":225,"class":39},"Brigham and Women's Hospital",2,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":242,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":259},"100471453","phase-2-a-study-of-stereotactic-radiosurgery-srs-for-people-with-lung-cancer-that-has-spread-to-the-brain-100471453","NCT05419076","A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain","A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n* Histologic diagnosis of small cell lung cancer\n* Radiographic diagnosis of up to 20 brain metastases on contrast-enhanced MRI\n* Age 18 and above\n* Performance status KPS 60-100\u002FECOG 0-2\n* Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment\n* The patient or legally authorized representative is able to provide informed consent\n\nExclusion Criteria:\n\n* Unable to undergo contrast-enhanced MRI brain\n* Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine\n* Pregnant or lactating women\n* Prior brain-directed radiotherapy\n* Uncontrolled systemic disease without reasonable systemic therapy options felt likely to result in death as observed on CT or PET\u002FCT imaging, no more than 3 months before study enrollment",{"count":235,"type":21},62,[51],"The purpose of the study is to see if stereotactic radiosurgery\u002FSRS is an effective treatment for people with a new diagnosis of brain metastases from small cell lung cancer\u002FSCLC.",[206,239,27,54,240,241],"Lung Cancer Metastatic","Small-cell Lung Cancer","Small Cell Lung Carcinoma",[243,244,245,246,247,248,249,250],"Stereotactic Radiosurgery","small cell lung cancer","small cell lung carcinoma","lung cancer","lung cancer metastatic","brain metastases","22-133","Memorial Sloan Kettering Cancer Center","2026-06-09",{"date":253,"type":32},"2026-06-10",{"date":255,"type":32},"2022-06-10",{"date":257,"type":21},"2027-06-10",{"name":250,"class":39},7,{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":20},"100327995","phase-3-stereotactic-radiosurgery-compared-with-hippocampal-avoidant-whole-brain-radiotherapy-ha-wbrt-plus-memantine-for-5-or-more-brain-metastases-100327995","NCT03550391","Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases","A Phase III Trial of Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases","Inclusion Criteria:\n\n* Patients must have 5 or more brain metastases as counted on a T1 contrast enhanced MRI obtained ≤ 30 days from randomization (maximum 15 brain metastases).\n* Patients must have a pathological diagnosis (cytological or histological) of a non-hematopoietic malignancy.\n* The largest brain metastasis must measure \\\u003C2.5 cm in maximal diameter.\n* Centre must have the ability to treat patients with either a Gamma Knife, Cyberknife, or a linear accelerator-based radiosurgery system.\n* Patient must be \\> 18 years of age.\n* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French either alone or with assistance.\n* ECOG performance status 0, 1, or 2.\n* Creatinine clearance must be ≥ 30 ml\u002Fmin within 28 days prior to registration.\n* The Neurocognitive Testing examiner must have credentialing confirming completion of the neurocognitive testing training.\n* Facility is credentialed by IROC to perform SRS and HA-WBRT. The treating centre must have completed stereotactic radiosurgery credentialing of the specific system(s) to be used in study patients. The treating centre must have completed IMRT credintialing of this specific IMRT systems to be used in study patients for the purposes of HA-WBRT.\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.\n* A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.\n* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* In accordance with CCTG policy, protocol treatment is to begin within 14 days of patient enrolment.\n* Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion Criteria:\n\n* Pregnant or nursing women.\n* Men or women of childbearing potential who are unwilling to employ adequate contraception.\n* Inability to complete a brain MRI.\n* Known allergy to gadolinium.\n* Prior cranial radiation therapy.\n* Planned cytotoxic chemotherapy within 48 hours prior or after the SRS or HA-WBRT.\n* Primary germ cell tumour, small cell carcinoma, or lymphoma.\n* Widespread definitive leptomeningeal metastasis. This includes cranial nerve palsy, leptomeningeal carcinomatosis, ependymal involvement, cranial nerve involvement on imaging, suspicious linear meningeal enhancement, or cerebrospinal fluid (CSF) positive for tumour cells.\n* A brain metastasis that is located ≤ 5 mm of the optic chiasm or either optic nerve.\n* Surgical resection of a brain metastasis (stereotactic biopsies will be allowed).\n* More than 15 brain metastases on a volumetric T1 contrast MRI (voxels of 1mm or smaller) performed within the past 14 days, or more than 10 metastases in the case of a non-volumetric MRI.\n* Prior allergic reaction to memantine.\n* Current alcohol or drug abuse.\n* Current use of NMDA antagonists, such as amantadine, ketamine, or dextromethorphan.\n* Diagnosis of chronic liver disease\u002Fcirrhosis of the liver (e.g. Child-Pugh class B or C).\n* Patients with architectural distortion of lateral ventricular systems, which, in the opinion of the local investigator, makes hippocampal delineation challenging",{"count":268,"type":21},206,[270],"PHASE3","Stereotactic radiosurgery (SRS) is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain.\n\nWhole brain radiation therapy with hippocampal avoidance (HA-WBRT) is when radiation therapy is given to the whole brain, while trying to decrease the amount of radiation that is delivered to the area of the hippocampus. The hippocampus is a brain structure that is important for memory. Memantine is a drug that is given to help relieve symptoms that can be caused by WBRT, including problems with memory and other mental symptoms.\n\nHealth Canada, the regulatory body that oversees the use of drugs in Canada, has not approved the sale or use of memantine in combination with WBRT to treat this kind of cancer, although they have allowed its use in this study.",[27],"2026-06-08",{"date":251,"type":32},{"date":276,"type":32},"2018-11-22",{"date":278,"type":21},"2027-12-31",{"name":280,"class":281},"Canadian Cancer Trials Group","NETWORK",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":292,"phases":4,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":40},"100643397","early-18f-fdg-pet-dynamic-analysis-in-brain-metastases-after-radiotherapy-100643397","NCT07632092","Early [18F]-FDG PET Dynamic Analysis in Brain Metastases After Radiotherapy.","Interest of Early Dynamic Analysis of [18F]-FDG PET Images in the Differential Diagnosis Between Recurrence and Radionecrosis in Brain Metastases.","DYNFDGTEP","Inclusion Criteria:\n\n* Patient referred for cerebral \\[18F\\]-FDG PET examination prescribed as part of his usual medical care for brain metastasis.\n* Age ≥ 18 years old\n* Affiliation to a social security program\n* Ability of the subject to understand and express his consent\n\nExclusion Criteria:\n\n* Age under 18 years old\n* Person under guardianship or curatorship\n* Pregnant or breastfeeding woman\n* Primary brain tumors\n* Brain metastases from renal, thyroid or other cancers known to have low avidity for \\[18F\\]-FDG",{"count":291,"type":21},50,"OBSERVATIONAL","Various treatment options are available for brain metastases, depending on factors such as lesion site or number lesions. Radiotherapy is a commonly used treatment. Following stereotactic radiotherapy for brain metastases, a potential complication, namely brain radionecrosis, can occur subsequently. It is essential to differentiate between this radionecrosis and lesion recurrence in order to determine the appropriate treatment approach. Contrast-enhanced magnetic resonance imaging (MRI) is the most widely used technique for monitoring brain metastases. Therefore, patients undergo routine MRI at 3 months and during subsequent follow-ups, but if the lesion evolve and if distinguishing between recurrence and radionecrosis is challenging, an \\[18F\\]-FDG PET scan is then prescribed by oncologists or radiotherapists during follow-up consultations. As part of the standard patient management protocol, a 10-minute image acquisition begins after a 45-60 minutes wait following the radiotracer injection. A second image acquisition is then conducted 3-4 hours later. For both acquisitions, a low-dose X-ray scanner is synchronously coupled to allow attenuation correction of the PET images.\n\nPatient for whom a \\[18F\\]-FDG PET cerebral examination has been prescribed as part of the usual management of brain metastases will be eligible to the protocol. If the patient agrees to participate, an early imaging session is initiated immediately upon radiotracer injection, lasting 15 minutes in addition to the standard acquisition protocol.",[295,27,101],"Short Time Examination",[297,295,27,101],"18F]-FDG PET","2026-06-02",{"date":273,"type":32},{"date":301,"type":32},"2026-05-18",{"date":303,"type":21},"2028-11-18",{"name":305,"class":39},"Centre Hospitalier Universitaire, Amiens",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":22,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":40},"100596369","medex-no-perioperative-dexamethasone-in-brain-metastases-100596369","NCT07044557","MeDex: No Perioperative Dexamethasone in Brain Metastases","Inclusion Criteria:\n\n1. New brain tumor(s) on imaging\n2. Visceral mass(es) suspicious or confirmed for neoplasm\n\n   a. Patients with lung mass suspicious for primary lung cancer and no prior diagnosis must undergo biopsy of the lung mass prior to resection of brain metastasis(es) to exclude histology (i.e., small cell lung carcinoma) that would not benefit from resection\n3. No contraindications for craniotomy\n4. Age ≥ 18 years\n5. ECOG performance status ≤ 2 (i.e., ambulatory \\> 50% of waking hours)\n6. Midline shift on MRI ≤ 10 mm\n7. Craniotomy planned to resect \\>75% of the enhancing mass (surgeon's judgment)\n\nExclusion Criteria:\n\n1. Presence of BMs not eligible for resection that are each \\> 2 cm in any one dimension\n2. \\>4 BMs not eligible for resection that are each 2 cm in any one dimension\n3. Treatment with laser interstitial thermal therapy (LITT)\n4. High concern for primary CNS lymphoma\n5. Diagnosis of small cell lung carcinoma\n6. Any receipt of Dex\n7. Steroid use in the past month\n8. A condition that requires steroids\n9. Stage 4 chronic kidney disease (GFR\\\u003C30)\n10. Pregnant or breastfeeding",{"count":313,"type":21},35,[98],"Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).",[27],"2026-05-28",{"date":319,"type":32},"2026-05-29",{"date":321,"type":21},"2026-08-01",{"date":323,"type":21},"2027-10",{"name":325,"class":39},"University of Louisville",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":339,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":40},"100519787","phase-1-18f-fluciclovine-pet-amino-acid-evaluation-of-brain-metastasis-treated-with-stereotactic-radiosurgery-100519787","NCT06048094","18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery","18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)","FACILITATE","Inclusion Criteria:\n\n* Diagnosis of cancer with radiographic finding of brain metastasis\n* Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension\n* Planned treatment with SRS as per the treating physician team\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET\n\nExclusion Criteria:\n\n* Prior anaphylactic reaction to 18F-fluciclovine\n* Radiographic evidence of leptomeningeal disease\n* Prior whole-brain radiation therapy\n* Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)\n* Pregnant or positive serum pregnancy test within 14 days of registration\n* Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed.\n* Major medical illness or psychiatric\u002Fcognitive impairments, which in the investigator's opinion, will prevent completion of protocol and\u002For preclude informed consent\\*\n\n  * A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.",{"count":335,"type":21},46,[24],"This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.",[27,54,204],[340,341,342],"stereotactic radiosurgery","18F-flucicloivine","PET imaging",{"date":344,"type":32},"2026-05-20",{"date":346,"type":32},"2024-04-11",{"date":348,"type":21},"2033-05",{"name":350,"class":39},"Baptist Health South Florida",{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":360,"briefSummary":361,"conditions":362,"keywords":363,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":40},"100570875","phase-2-trial-of-relatlimab-nivolumab-and-ipilimumab-in-patients-with-asymptomatic-and-symptomatic-melanoma-brain-metastases-100570875","NCT06712927","Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases","A Multicenter, Phase II Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases","Inclusion Criteria:\n\n1. Histologically confirmed non-uveal melanoma that has metastasized to the brain. At least 1 measurable intracranial target lesion (5-40mm) which was not previously treated with local therapy (no prior SRS to this lesion). Prior surgery for a brain metastasis is allowed but this lesion cannot be a target lesion.\n\n   a. Growth or change in a lesion previously irradiated will not be considered measurable. Regrowth in cavity of previously excised lesion will not be considered measurable.\n2. Age ≥ 18 years\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 for Cohort A (asymptomatic), ECOG performance status 0-2 for Cohort B (symptomatic)\n4. No prior anti-CTLA-4, anti-PD-1, or anti-LAG-3 therapy for unresectable stage III\u002FIV melanoma. Prior CTLA-4, PD-1, and\u002For LAG-3 therapy in the neoadjuvant or adjuvant setting is acceptable if \\>6 months since last treatment. Participants may have had prior BRAF+MEK inhibitors for adjuvant therapy and\u002For unresectable\u002Fmetastatic melanoma if \\>2 weeks have elapsed since last treatment.\n5. Adequate organ function as assessed by the following parameters:\n\n   1. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (≤ 3 ×ULN); patients with liver metastasis ≤ 5 × ULN\n   2. Estimated creatinine clearance (eCrCl) ≥ 30 mL\u002Fmin using the Cockcroft-Gault formula at Screening\n   3. Total bilirubin ≤ 1.5x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\>1.5x ULN\n6. Patients must have recovered from all prior anti-cancer therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] v 5.0), except for alopecia, vitiligo, thyroid dysfunction, hypophysitis, or adrenal insufficiency, prior to enrollment.\n7. Cohort A (asymptomatic): participants must be free of neurologic signs and symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy greater than physiologic replacement (\\>10 mg of prednisone\u002Fday or equivalent) in the 10 days prior to beginning protocol therapy. Cohort B (symptomatic): participants may be on steroids with doses no higher than a total daily dose of 4 mg of dexamethasone or equivalent that is stable or tapering within 10 days prior to treatment. Patients who are symptomatic and are not being treated with steroids are also eligible.\n8. Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to treatment.\n9. Participants with a known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection must have been treated and cured. Participants with HBV or HCV infection who are currently on treatment must have an undetectable HCV viral load prior to treatment.\n10. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) OR at least 4 unstained slides, with an associated pathology report, for testing of tumor PD-L1 expression:\n\n    1. Tumor tissue should be of good quality based on total and viable tumor content.\n    2. Patients who do not have tissue specimens may undergo a biopsy during the screening period. Acceptable samples include core-needle biopsies for deep tumor tissue or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. Fine Needle Aspirations (FNA) will not be considered acceptable for tissue procurement.\n    3. Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable.\n    4. However, if repeat biopsy is not feasible, and no archival tissue available patient still may be enrolled.\n11. Any radiation treatment or excision of non-target brain lesions must have occurred ≥ 1 weeks before the start of dosing for this study. NOTE: The radiation field must not have included the brain index lesion(s).\n12. Radiation to non-CNS lesions is allowed and does not require a washout period for treatment initiation. Any radiation-related toxicity must have recovered to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] v 5.0).\n13. Women of child-bearing potential (WOCBP) must not be breastfeeding and must have a negative pregnancy test within 3 days prior to initiation of dosing. WOCBP (or female partners of male participants) must agree to use an acceptable method of birth control from the time of the negative pregnancy test, through the duration of treatment with the study combination and for 12 months after their last dose of any study component medication.\n\n    NOTE: A female participant is eligible to participate if she is not a woman of childbearing potential.\n\n    Approved methods of birth control are as follows:\n\n    Combined (estrogen and progesterone containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal Progesterone-only hormonal birth control associated with inhibition of ovulation: oral, injectable, implantable Intrauterine device (IUD) Intrauterine hormone-releasing system (IUS) Bilateral tubal occlusion Vasectomized partner True sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) is not acceptable\n14. Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC) and agree to abide by the study restrictions and return to the site for the required assessments.\n\nExclusion Criteria\n\n1. Another primary malignancy within the previous 3 years (with the exception of carcinoma in situ of the breast, cervix, or bladder; localized prostate cancer; and non-melanoma skin cancer that has been adequately treated).\n2. Active medical illness(es) that would pose increased risk for study participation, including: active systemic infections (including COVID-19), coagulation disorders, or other major active medical illnesses of the cardiovascular, respiratory, or immune systems.\n3. Active autoimmune disease that has required systemic therapy with corticosteroids or other immunosuppressive agents within the past 3 years (excluding immune-related adverse events from immunotherapy as described above.\n4. Implanted device that precludes the use of MRI.\n5. Prior Grade 4 treatment-related AE with immune checkpoint inhibitor treatment.\n6. History of leptomeningeal metastasis determined by imaging or lumbar puncture.\n7. Prior whole brain radiation therapy (WBRT)\n8. Women who are breast-feeding or pregnant\n9. History of clinically significant cardiac disease or congestive heart failure \\> New York Heart Association (NYHA) class 2. Subjects must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months or a history of myocarditis\n10. Troponin T (TnT) or I (TnI) \\> 2 × institutional ULN. Participants with TnT or TnI levels between \\> 1 to 2 × ULN will be permitted if repeat levels within 24 hours are ≤ 1 ULN. If TnT or TnI levels are between \\>1 to 2 × ULN within 24 hours, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \\\u003C 2 × ULN, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation. Notification of the decision to enroll the participant following cardiologist recommendation has to be made to the principal investigator.\n11. Investigational drug use within 14 days (or 5 half-lives, whichever is longer) of the first dose of study treatment.\n12. Dexamethasone use \\> 4mg\u002Fday (or equivalent)",{"count":359,"type":21},60,[51],"This is a multicenter, phase II trial of relatlimab (rela), nivolumab (nivo), and ipilimumab (ipi) in patients with asymptomatic and symptomatic melanoma brain metastases.",[205,27],[364,365,366],"Relatlimab","Nivolumab","Ipilimumab","2026-05-15",{"date":301,"type":32},{"date":370,"type":32},"2025-08-06",{"date":372,"type":21},"2030-02",{"name":374,"class":39},"Stanford University",{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":388,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":40},"100608136","iomri-in-the-surgery-of-brain-metastases-100608136","NCT07197632","ioMRI in the Surgery of Brain Metastases.","Evaluation of the Efficacy and Safety of Intraoperative MRI in the Surgery of Brain Metastases.","MET-MRI","Inclusion Criteria:\n\n* Patients for whom surgical resection of brain metastasis is indicated\n\nExclusion Criteria:\n\n* age \\\u003C 18\n* 3T MRI contraindications",{"count":384,"type":21},154,[98],"The study aims to improve the surgical treatment of brain metastases through the use of advanced imaging techniques. The investigators are examining how intraoperative MRI (iMRI) can aid surgeons in precisely locating and removing tumors, with the potential to enhance surgical outcomes and reduce the need for additional procedures. While iMRI offers the promise of better tumor visualization during surgery, it is also associated with longer surgical times and may carry the risk of increased complications. This study seeks to carefully evaluate these aspects to determine the overall benefits and challenges of iMRI in brain metastasis surgeries. The ultimate aim is to enhance treatment effectiveness and improve recovery and health outcomes for participants dealing with brain metastases.",[27],[389,390,391],"ioMRI","Brain metastases","Neurosurgical resection","2026-05-03",{"date":394,"type":32},"2026-05-05",{"date":396,"type":32},"2025-01-17",{"date":398,"type":21},"2030-01-01",{"name":400,"class":39},"Technical University of Munich",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":409,"enrollmentInfo":410,"targetDuration":4,"studyType":22,"phases":412,"briefSummary":413,"conditions":414,"keywords":415,"overallStatus":418,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":423,"leadSponsor":425,"locationsCount":40},"100636713","phase-1-il-8-receptor-modified-patient-derived-activated-cd70-car-t-cell-therapy-in-adults-with-brain-metastases-100636713","NCT07569263","IL-8 Receptor Modified Patient-Derived Activated CD70 CAR T Cell Therapy in Adults With Brain Metastases","A Phase I Study to Assess Safety and Feasibility of IL-8 Receptor Modified Patient-Derived Activated CD70 CAR T Cell Therapy in Adults With Brain Metastases From Primary Cancers (IMPACT-MET)","IMPACT MET","Inclusion Criteria:\n\n* Histological confirmation of primary cancers\n* Histologic confirmation of CD70 on primary tumor, lymph node, or BM biopsy\n* At least one recurrent or progressive metastatic lesion or new metastatic lesion(s).\n* KPS ≥ 70.\n* 18 years or older.\n* Adequate bone marrow and organ function as defined below:\n\n  * CBC with differential with adequate bone marrow function as defined below:\n  * Absolute neutrophil count (ANC) ≥ 10000 cells\u002Fmm3.\n  * Platelet count ≥ 75,000 cells\u002Fmm3.\n  * Hemoglobin ≥ 9 g\u002Fdl. (use of transfusion or other intervention to achieve Hgb ≥ 9 g\u002Fdl is acceptable.)\n* Adequate renal function as defined below:\n\n  * BUN ≤ 25 mg\u002Fdl\n  * Creatinine ≤ 1.7 mg\u002Fdl\n* Adequate hepatic function as defined below:\n\n  * Bilirubin ≤ 2.0 mg\u002Fdl\n  * ALT ≤ 5 times institutional upper limits of normal for age\n  * AST ≤ 5 times institutional upper limits of normal for age\n* A diagnostic contrast-enhanced brain MRI must be performed within 28 days prior to study enrollment.\n* For females of childbearing potential, a negative serum pregnancy test at enrollment.\n* Women of childbearing potential (WOCBP) must be willing to use an acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.\n* Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of the study drug.\n* Ability of the patient to understand and willingness to sign an IRB approved written informed consent document.\n* Steroid dose equivalent to dexamethasone dose of ≤ 6mg daily at the time of enrollment.\n* Patients treated on any other investigational therapy must discontinue that treatment prior to study entry.\n\nExclusion Criteria:\n\n• Known immunosuppressive disease or human immunodeficiency virus (HIV) infection.\n\nRationale: The need to exclude patients with an immunosuppressive disease or human immunodeficiency virus infection is necessary because the management of potential toxicities from the study drug may involve treatment that is significantly immunosuppressive.\n\n* Participant has ongoing toxicity ≥ grade 2 per the CTCAE version 5.0 considered clinically significant and in the opinion of the investigator, attributable to prior antineoplastic therapies.\n* Participant has received any chemotherapy or other immunotherapy within 14 days prior to the first dose of study intervention.\n* Severe, active co-morbidity, defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization.\n  * Transmural myocardial infarction within the last 6 months.\n  * Acute bacterial or fungal infection requiring intravenous antibiotics.\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization.\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects.\n  * Patients with an autoimmune disease requiring medical management with immunosuppressants.\n  * Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.\n* Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant.","80 Years",{"count":411,"type":21},12,[24],"This is a Phase I Study evaluating the safety and feasibility of IL-8 receptor-modified patient-derived activated CD70 CAR T cells in adult patients with brain metastases from primary cancer, with either newly diagnosed lesions or recurrent or progressive disease after prior therapy.",[27],[416,417],"Immunotherapy","CAR T cells","NOT_YET_RECRUITING","2026-04-29",{"date":421,"type":32},"2026-05-06",{"date":84,"type":21},{"date":424,"type":21},"2044-12",{"name":426,"class":39},"University of Florida",{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":434,"sex":17,"minAge":18,"maxAge":435,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":437,"briefSummary":438,"conditions":439,"keywords":442,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":226},"100523850","development-of-mrf-for-characterization-of-brain-tumors-after-radiotherapy-100523850","NCT06101069","Development of MRF for Characterization of Brain Tumors After Radiotherapy","Development of Magnetic Resonance Fingerprinting for Characterization of Brain Tumors After Radiotherapy","Inclusion Criteria for Healthy Participants:\n\n* Ages 18 - 60\n* No history of cerebrovascular disease\n* No cognitive impairments\n* Able to provide informed consent\n\nInclusion Criteria for Participants with Brain Tumors:\n\n* Biopsy-proven cases of developed recurrent tumor or radiation necrosis, OR\n* a. PET identified with developed recurrent tumor or radiation necrosis. OR\n* b. Highly suspicious case with developed recurrent tumor or radiation necrosis confirmed by tumor board, attending physician or surgeon.\n* ECOG performance status 0-2.\n* Life expectancy \\> 6 months.\n* Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.\n\nInclusion Criteria for Participants with Brain Metastases or Primary Gliomas:\n\n* Radiology identified with developed primary gliomas tumor or brain metastases, OR\n* a. PET identified with developed gliomas tumor or brain metastases, OR\n* b. Highly suspicious case with developed gliomas tumor or brain metastases confirmed by tumor board\n* Participants must not have received prior radiation or surgical treatment for brain metastases or primary glioma.\n* Age: 18 years and over\n* ECOG performance status 0-2\n* Life expectancy \\> 6 months.\n* Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.\n\nInclusion Criteria for Participants with Meningiomas:\n\n* Radiology identified with resectable meningioma\n* Participants have no prior radiation or surgical treatment for brain lesions\n* Age: 18 years or older\n* ECOG performance status 0-2\n* Life expectancy \\> 6 months.\n* Participants with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.\n\nExclusion Criteria:\n\n* Pregnant women OR lactating women\n* Participants with ferromagnetic or otherwise non-MRI compatible aneurysm clips.\n* Participants who cannot go into the MRI scanner due to metal implants and other medical conditions.\n* The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator.\n* Participants with contraindications for MRI due to embedded foreign metallic objects such as bullets, shrapnel, metalwork fragments, or other metallic material.\n* Known history of severe claustrophobia.\n* Participants unable to lay still in the scanner for 30 minutes at a time.",true,"60 Years",{"count":73,"type":21},[98],"The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, individuals with previously untreated tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study.\n\nThe primary objectives of this study are:\n\n* To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage.\n* To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis.\n* To investigate the effect of radiation dose on the development of radiation necrosis and tumor recurrence.",[216,440,27,441],"Brain Necrosis","Glioma",[443,444],"Magnetic Resonance Fingerprinting","Radiation necrosis",{"date":394,"type":32},{"date":447,"type":32},"2024-10-14",{"date":449,"type":21},"2026-09",{"name":88,"class":39},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":22,"phases":460,"briefSummary":461,"conditions":462,"keywords":463,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":472,"locationsCount":226},"100442789","phase-2-optimizing-neurocognition-with-whole-brain-radiation-therapy-wbrt-using-upfront-pulsed-reduced-dose-rate-prdr-technique-100442789","NCT05045950","Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique","Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy for Brain Metastases","Inclusion Criteria:\n\n1. Age ≥18 years at diagnosis of brain metastases.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Score of \\\u003C2.\n3. Participants must have a biopsy-proven solid malignancy (histologic proof or unequivocal cytologic proof solid tumor malignancy from either the primary or any metastatic site) with intracranial lesions radiographically consistent with or pathologically proven to be brain metastases.\n4. Patients who have undergone prior systemic therapy are eligible.\n5. Life expectancy from extracranial disease greater than six months.\n6. Patients with measurable brain metastasis.\n7. Patients may have had prior therapy for brain metastasis, including stereotactic radiosurgery (SRS)and surgical resection. Patients must have completed prior therapy by at least 7 days prior to study enrollment for SRS and at least 14 days for surgical resection\n8. If an open biopsy is performed, the patient must be at least one-week post-biopsy. This requirement is not necessary for stereotactic biopsies.\n9. Creatinine clearance is ≥ 30 mL\u002Fmin.\n10. Start of PRDR WBRT within two weeks following registration.\n11. Ability to complete the Neurocognitive Function (NCF) test battery (including people whose primary language is English).\n12. Patients with previous or other malignancies whose disease is controlled and not impacting ECOG performance or life expectancy.\n13. Willing and able to give consent and to comply with treatment and follow-up schedule.\n\nExclusion Criteria:\n\n1. Metastases from hematological malignancy, or central nervous system malignancy.\n2. Patients whose malignancy is being treated with curative intent.\n3. Leptomeningeal metastases.\n4. Contraindication to MRI imaging with contrast.\n5. Contraindication to memantine including concurrent use of N-methyl-D-aspartate (NMDA) antagonists.\n6. Stage IV-V chronic kidney disease or end-stage renal disease.\n7. Participants with a maximum tumor diameter exceeding 5 cm (if not resected).\n8. Prior cranial whole brain radiation therapy.\n9. Past medical history of dementia which is thought to be unrelated to the brain metastases.\n10. Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of the course of radiotherapy.\n11. Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician, prevent informed consent or completion of protocol treatment, and\u002For follow-up visits.\n12. Non-native English speakers will be excluded since patients often lose their faculty with the language they acquired second before their native language is affected in the context of cognitive decline. This could adversely affect performance on verbal cognitive tasks.",{"count":459,"type":21},53,[51],"Study patients will receive Whole-brain radiation therapy (WBRT) - pulsed reduced dose rate (PRDR) within 14 days of registration. All patients will receive single daily fractions using 3D conformal radiotherapy. A dose of 30 Gy in 10 fractions will be delivered using the PRDR technique.",[27],[464,465],"whole-brain radiation therapy","upfront pulsed reduced dose-rate","2026-04-27",{"date":468,"type":32},"2026-05-01",{"date":470,"type":32},"2021-11-17",{"date":223,"type":21},{"name":473,"class":39},"Medical College of Wisconsin",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":481,"minAge":18,"maxAge":482,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":484,"briefSummary":485,"conditions":486,"keywords":488,"overallStatus":418,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":40},"100634443","phase-2-brain-radiotherapy-combined-with-dalpiciclib-and-endocrine-therapy-in-hr-positiveher2-negative-advanced-breast-cancer-with-brain-metastases-100634443","NCT07539753","Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive\u002FHER2-Negative Advanced Breast Cancer With Brain Metastases","A Single-Arm, Phase II Study of Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive\u002FHER2-Negative Advanced Breast Cancer Patients With Brain Metastases","Inclusion Criteria:\n\n* 1.Female patients aged 18 to 75 years, who are postmenopausal or premenopausal\u002Fperimenopausal, and meet at least one of the following conditions:\n\n  1. prior bilateral oophorectomy; or age ≥60 years; or\n  2. age \\\u003C60 years and postmenopausal status defined as at least 12 consecutive months of spontaneous amenorrhea without other pathological or physiological causes, with estradiol (E2) and follicle-stimulating hormone (FSH) levels within the postmenopausal range; or\n  3. premenopausal or perimenopausal women are also eligible if they are willing to receive treatment with an LHRH agonist during the study.\n* 2.Histologically or cytologically confirmed HR-positive, HER2-negative breast cancer in female patients, with evidence of locally recurrent or metastatic disease that is not amenable to curative surgery or radiotherapy, and with no clinical indication for chemotherapy.\n* HR-positive is defined as ER-positive and\u002For PR-positive, with ≥1% of tumor cells showing positive staining, as confirmed by the investigator at the study site.\n* HER2-negative is defined as IHC 0 or 1+, or ISH-negative, defined as a HER2\u002FCEP17 ratio \\\u003C2.0 or an average HER2 copy number \\\u003C4.0, as confirmed by the investigator at the study site.\n* 3.Presence of brain metastases confirmed by MRI, with at least one measurable intracranial lesion ≥1 cm according to RECIST version 1.1. Measurable extracranial disease is not required.\n* 4.ECOG performance status 0-2, and an estimated life expectancy of at least 12 weeks at the time of enrollment.\n* 5.If the patient is receiving corticosteroids, the corticosteroid dose must be stable or decreasing for at least 5 days before the brain gadolinium-enhanced MRI (Gd-MRI). This MRI must be performed within 28 days before enrollment. Patients who require an increased steroid dose before treatment, or who are receiving an unstable steroid dose, are not eligible.\n* 6.Screening laboratory values must meet the following criteria( and should be obtained within 14 days prior to registration)::\n\n  1. absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³ (1.5 × 10\\^9\u002FL), without growth factor support within 14 days;\n  2. platelet count (PLT) ≥ 100,000\u002Fmm³ (100 × 10\\^9\u002FL), without corrective treatment within 7 days;\n  3. hemoglobin (Hb) ≥ 9 g\u002FdL (90 g\u002FL), without corrective treatment within 7 days;\n  4. serum creatinine (Scr) ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance ≥ 60 mL\u002Fmin;\n  5. total bilirubin ≤ 1.5 × ULN;\n  6. aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 2.5 × ULN, or ≤ 5 × ULN for patients with liver metastases.\n* 7.Prior stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSRT) is permitted, provided that the currently active measurable disease has not been previously treated with radiotherapy.\n* 8.Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and must agree to use a medically acceptable highly effective method of contraception during the study and for 1 year after the last dose of study treatment.\n* 9.Ability and willingness to signed the informed consent form prior to patient entry.\n\nExclusion Criteria:\n\n* 1.Prior pathological diagnosis of HER2-positive breast cancer.\n* 2.Prior disease progression on dalpiciclib in the metastatic setting.\n* 3.Primary endocrine resistance, defined as either:\n\n  1. disease recurrence or progression within 2 years of starting adjuvant endocrine therapy; or\n  2. disease progression within 6 months of first-line endocrine therapy for advanced or metastatic disease.\n* 4.Patients considered not suitable for endocrine therapy in the judgment of the investigator, including patients with symptomatic visceral disease, disseminated visceral involvement, or a risk of life-threatening complications in the short term, such as uncontrolled massive effusions (pleural, pericardial, or peritoneal), lymphangitic carcinomatosis of the lung, or \\>50% liver involvement.\n* 5.Presence of leptomeningeal metastases.\n* 6.Prior whole-brain radiotherapy (WBRT) .\n* 7.Any severe neurologic symptoms caused by central nervous system metastases.\n* 8.Pregnant or breastfeeding women.\n* 9.Any serious uncontrolled clinical disease or infection that, in the investigator's judgment, cannot be adequately controlled with appropriate treatment or may impair the patient's ability to tolerate study treatment, including but not limited to:\n\n  1. serious cardiovascular events such as syncope of cardiovascular origin, pathologic ventricular arrhythmias (including but not limited to ventricular tachycardia or ventricular fibrillation), or cardiac arrest;\n  2. end-stage renal disease;\n  3. severe liver disease;\n  4. active systemic bacterial infection.\n* 10.History of immunodeficiency, including HIV infection, active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, other acquired or congenital immunodeficiency disorders, or prior organ transplantation.\n* 11.History of malignancy other than breast cancer.\n* 12.Inability to swallow oral medication, or presence of chronic diarrhea, intestinal obstruction, or other conditions that may interfere with the administration or absorption of study drugs.\n* 13.History of allergy or hypersensitivity to any study drug or any of its components.","FEMALE","75 Years",{"count":335,"type":21},[51],"This is a prospective, open-label, exploratory clinical trial designed to evaluate the efficacy and safety of brain radiotherapy combined with dalpiciclib and endocrine therapy in HR-positive\u002FHER2-negative advanced breast cancer patients with brain metastases. A total of 46 patients are planned to be enrolled.\n\nParticipants will receive dalpiciclib plus endocrine therapy and brain radiotherapy, including fractionated stereotactic radiotherapy (FSRT) or whole-brain radiotherapy (WBRT), according to the clinical characteristics of brain metastatic lesions. Radiotherapy may start within 30 days before or after initiation of drug treatment. Dalpiciclib and endocrine therapy may be given concurrently during radiotherapy and will be continued after radiotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or investigator decision. Participants will visit the clinic once every 3 months for checkups and tests. Tumor response will be assessed according to RECIST version 1.1, and safety will be evaluated throughout the study.",[207,27,487],"HR+\u002FHER2- Breast Cancer",[487,248,489,490],"brain radiotherapy","dalpiciclib","2026-04-24",{"date":493,"type":32},"2026-04-30",{"date":495,"type":21},"2026-06-01",{"date":497,"type":21},"2029-08-01",{"name":499,"class":39},"Nanfang Hospital, Southern Medical University",{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":509,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":40},"100415393","phase-1-assess-use-of-18f-fluciclovine-for-patients-with-large-brain-metastases-treated-with-staged-stereotactic-radiosurgery-100415393","NCT04689048","Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery","Characterization of Large Brain Metastases With 18F-Fluciclovine PET\u002FCT Treated With Staged Stereotactic Radiosurgery","Inclusion Criteria:\n\n1. Male or female, age ≥18 years\n2. Performance status, Eastern Cooperative Oncology Group 0-2\n3. Confirmed diagnosis of brain metastases with at least one untreated lesion \\>2 cm in maximum diameter\n4. Plan for SSRS per the treating team\n5. For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required\n6. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-fluciclovine positron emission tomography\u002Fcomputerized tomography\n\nExclusion Criteria:\n\n1. Prior anaphylactic reaction to 18F-fluciclovine\n2. Evidence of leptomeningeal disease\n3. Prior whole-brain radiation therapy\n4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)\n5. Females pregnant at the expected time of 18F-fluciclovine administration\n6. Females who are expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed\n7. Major medical illness or psychiatric\u002Fcognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and\u002For preclude informed consent",{"count":508,"type":21},20,[24],"The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.",[54,27,204],[513,248,514,515,243],"brain","brain metastases, adult","brain cancer","2026-04-20",{"date":518,"type":32},"2026-04-22",{"date":520,"type":32},"2022-04-04",{"date":522,"type":21},"2027-12",{"name":350,"class":39},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":533,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":40},"100628505","phase-2-inflammation-in-primary-and-secondary-malignancies-of-the-central-nervous-system-using-c-11-cs1p1-100628505","NCT07462507","Inflammation in Primary and Secondary Malignancies of the Central Nervous System Using [C-11]-CS1P1","Investigation of Inflammation in Primary and Secondary Malignancies of the Central Nervous System Using [C-11]-CS1P1","Inclusion Criteria:\n\n* Male or female, any race\n* Age ≥ 18 years\n* Capable of providing written informed consent OR having a legally authorized representative (LAR) to provide informed consent for volunteering to undergo research procedure\n* Has a clinical, radiographic, or pathological diagnosis of primary or secondary CNS malignancy that has not been treated with radiotherapy\n\nExclusion Criteria:\n\n* Hypersensitivity to \\[C-11\\]-CS1P1 or any of its excipients\n* Contraindications to PET, CT or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate\n* Prior cranial radiotherapy\n* Severe claustrophobia that would require general anesthesia\n* Women who are currently pregnant or breastfeeding\n* Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with the collection of the data (e.g., advanced renal or liver failure)\n* Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcdrh\u002Fcfdocs\u002Fcfcfr\u002FCFRSearch.cfm?FR=361.1.",{"count":532,"type":21},104,[51],"Adult patients with primary or secondary central nervous system malignancies will be invited to undergo a baseline \\[C-11\\]-CS1P1 PET scan and a follow-up scan within 24 months of the baseline scan (preferably within 6-months post-treatment).The study will describe patterns of tracer uptake in tumors and normal brain and explore how these patterns relate to MRI findings, treatments received, and clinical outcomes.",[536,27],"Central Nervous System Cancer",[538,441,539,540,541,542],"Primary brain tumor","Glioblastoma","Astrocytoma","Oligodendroglioma","Brain metastasis","2026-04-17",{"date":545,"type":32},"2026-04-21",{"date":547,"type":32},"2026-04-16",{"date":549,"type":21},"2033-06-30",{"name":551,"class":39},"Washington University School of Medicine",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":22,"phases":561,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":570,"locationsCount":40},"100440330","phase-2-nts-wbrt-in-brain-metastases-100440330","NCT05013892","NTS-WBRT in Brain Metastases","Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) in Patients With Brain Metastases","Inclusion Criteria:\n\n* Any patient with a solid tumor diagnosis and any number of brain metastasis clinically indicated for cranial irradiation with whole brain radiation therapy\n* Age ≥ 18\n* Karnofsky Performance Status ≥ 70\n* Prior stereotactic radiosurgery (SRS) permissible per physician discretion\n* Prior craniotomy permissible per physician discretion. Protocol radiation therapy should be initiated ≥2 weeks after craniotomy.\n* Prior partial brain radiation therapy permissible if target volume \\\u003C 50% brain and per physician discretion\n* Expectant \\> 6 months survival\n* Ability to understand and the willingness to sign a written informed consent document.\n* Fluency in English, able to complete questionnaires and neurocognitive testing\n* Ability to undergo MRI with gadolinium examination\n* Ability to return for follow-up examinations throughout the course of this study for a maximum of 2 years after radiation treatment completion\n* Any prior, concomitant, or post-radiotherapy systemic therapy is permitted at discretion of treating physicians\n* Negative pregnancy test for premenopausal women\n\nExclusion Criteria:\n\n* Leptomeningeal disease (by any one or more of clinical assessment, radiographic assessment, or cerebrospinal fluid study)\n* Prior whole brain radiation therapy\n* Pre-existing or current use of memantine or other NMDA antagonists\n* Known allergy to contrast used in imaging studies and\u002For inability to have MRI imaging\n* Uncontrolled intercurrent illness that could significantly affect baseline cognitive function as determined by the enrolling clinician, such as symptomatic congestive heart failure, unstable angina pectoris, prior CVA, significant uncontrolled epilepsy or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or unwilling to use appropriate contraception to prevent pregnancy during the time of radiation therapy\n* Concurrent participation in an investigational systemic therapy protocol.",{"count":560,"type":21},41,[51],"This research is being done to assess the quality of life and symptom burden in participants who receive (normal tissue sparing whole brain radiation therapy (NTS-WBRT).\n\nThis research study involves:\n\n* NTS-WBRT (normal tissue sparing whole brain radiation therapy)\n* Memantine standard of care drug",[27],[27],"2026-04-14",{"date":547,"type":32},{"date":568,"type":32},"2022-02-08",{"date":278,"type":21},{"name":571,"class":39},"Massachusetts General Hospital",{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":581,"briefSummary":582,"conditions":583,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":40},"100565967","phase-2-exclaim-exploring-combined-local-and-systemic-approaches-in-brain-metastasis-a-multi-cohort-randomized-phase-ii-study-evaluating-initial-response-to-systemic-therapy-and-subsequent-integration-of-stereotactic-radiosurgery-in-patients-with-low-risk-brain-metastases-and-central-nervous-system-active-100565967","NCT06649058","EXCLAIM: Exploring Combined Local and Systemic Approaches In Brain Metastasis: a Multi-cohort Randomized Phase II Study Evaluating Initial Response to Systemic Therapy and Subsequent Integration of Stereotactic Radiosurgery in Patients With Low-risk Brain Metastases and Central Nervous System-active","EXCLAIM: Exploring Combined Local and Systemic Approaches In Brain Metastasis: a Multi-cohort Randomized Phase II Study Evaluating Initial Response to Systemic Therapy and Subsequent Integration of Stereotactic Radiosurgery in Patients With Low-risk Brain Metastases and Central Nervous System-active Systemic Therapy Options","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Evaluation by a brain metastasis multidisciplinary team (BM-MDT) consisting of a medical oncologist (can be the patient's primary medical oncologist), a radiation oncologist who regularly performs SRS, and a neurosurgeon. This evaluation can take place in clinic or during a multidisciplinary conference.\n3. Life expectancy \\> 6 months as estimated by BM-MDT.\n4. BM-MDT agreement that the planned systemic therapy regimen may provide intracranial benefit (SD, PR, or CR in the CNS).\n5. BM-MDT agreement that the patient's BM does not require immediate local therapy (surgery and\u002For radiation therapy); i.e. it is judged to be safe to omit local therapy as initial BM management.\n6. The patient's BM are amenable to SRS as initial local therapy as determined by BM-MDT.\n7. Subjects must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\n8. Histologically confirmed metastatic cancer with at least one measurable metastasis in the brain (≥ 5 mm).\n9. At least one measurable intracranial target lesion which was not previously treated with SRS. Regrowth in a cavity of previously excised lesion will not qualify as a measurable lesion. Growth or change in a lesion previously irradiated will not qualify as a measurable lesion.\n10. Prior SRS and prior excision of BM is permitted if other measurable non irradiated lesions as described in #9 remain.\n11. The resection cavity of excised BM must have received appropriate radiation therapy (pre or post operative SRS, brachytherapy) or have been observed for \\>6 months after resection without evidence of local cavity recurrence.\n12. Subjects must be free of neurologic signs and symptoms related to metastatic brain lesions either without systemic corticosteroids or requiring ≤ 2 mg dexamethasone daily for symptom resolution.\n13. ECOG performance status ≤ 1.\n14. Documented agreement by the patient's primary medical oncologist with the appropriateness of planned SST regimen.\n15. This study will allow non-English speaking subjects to be enrolled. Verbal Translation Preparative Sheet (VTPS) will be used if a translated consent form is not available in the subject's language. The consent form will be translated into the language of the subject after 2 or more occurrences. This will apply to any MD Anderson patient.\n\nExclusion Criteria:\n\n1. History of known leptomeningeal involvement (radiographic or cytological).\n2. Small cell lung cancer, lymphoma, or leukemia histology.\n3. Non-small cell lung cancer histology with targetable oncogenic driver mutation with planned initiation of highly CNS active targeted therapy (eg osimertinib, brigatinib, alectinib, or lorlatinib).\n4. Subjects previously treated with WBRT.\n5. Any intact BM size \\> 3 cm. After surgical excision and appropriate radiation therapy to the cavity, patients may enroll if additional eligible lesions are present.\n6. Prior disease progression on one or more of the agents comprising SST.\n7. Exposure to one or more agents comprising SST within the last 30 days.\n8. Prior unacceptable toxicity during treatment with one or more agents comprising SST.\n9. Subjects with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.\n10. History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful treatment of superficial bladder cancer, in situ cervical cancer, ductal carcinoma in situ, or other in-situ cancers. Subjects with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible.\n11. Skin Cancer Exclusion: Please note that localized cutaneous basal cell carcinoma and squamous cell carcinoma is not an exclusion criterion regardless of treatment status. Biopsy proven metastatic disease from these histologies is an exclusion criterion if this constitutes a second cancer.\n12. Patient weight \\>450 pounds.\n13. Patient had prior SRS to any intracranial lesion \\\u003C15mm from a metastasis on the screening MRI. Prior MRIs and DICOMs will be used to make this determination.\n14. Patient unable to receive a brain MRI (implanted metal devices or foreign bodies) or MRI contrast.\n15. Any BM with a significant hemorrhagic component (defined as MRI T1 intrinsic hyperintensity comprising ≥ 25% of maximal lesion diameter).",{"count":580,"type":21},316,[51],"To learn if consolidative stereotactic radiosurgery (cSRS) can help to control central nervous system (CNS) disease in patients who have brain metastases and have a partial response or stable brain metastases after systemic therapy.\n\nTo learn if using SRS to treat all brain metastases that do not respond to systemic therapy versus treating only metastases that are getting worse can help to control CNS disease in patients whose disease gets worse after systemic therapy.",[27],"2026-04-13",{"date":586,"type":32},"2026-04-15",{"date":588,"type":32},"2025-02-14",{"date":590,"type":21},"2030-09-30",{"name":592,"class":39},"M.D. Anderson Cancer Center",{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":22,"phases":600,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":40},"100444196","phase-2-phase-ii-study-of-pembrolizumab-in-combination-with-lenvatinib-in-patients-with-tnbc-nsclc-and-other-tumor-types-and-brain-metastases-100444196","NCT05064280","Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases","Inclusion Criteria:\n\nPatients are eligible to be included in the study only if all the following criteria apply:\n\n1. Male\u002Ffemale patients who are at least 18 years of age on the day of signing informed consent with histologically or cytologically confirmed TNBC (Cohort 1), NSCLC (Cohort 2), or solid tumors other than TNBC and NSCLC (Cohort 3) with brain metastasis and with or without active extracranial disease will be enrolled in this study.\n2. Has at least 1 measurable brain metastasis: Presence of at least 1 independently verified measurable brain metastasis in accordance with mRECIST (Appendix 1) that can be accurately assessed at baseline and suitable for accurate repeated measurements and with a tumor diameter of 0.5-3 cm on magnetic resonance imaging \\[MRI\\]).\n\n   * Previous SRS and excision of up to 5 brain metastases are permitted at least 3 weeks prior to study treatment initiation, provided that neurologic sequelae have completely resolved and measurable untreated lesion(s) remain. If the patient had prior whole brain radiation therapy or SRS, progression in any measurable brain metastasis must have occurred at least 1 month after the end of radiation therapy for the irradiated lesion to be counted as measurable.\n   * Patients can have asymptomatic (no neurologic signs or symptoms, not requiring immediate local intervention \\[surgery or radiosurgery\\] or systemic glucocorticoid therapy \\[within 10 days prior to study treatment initiation\\]) OR minimally symptomatic brain metastases (requiring ≤10 mg prednisone or equivalent per day and not requiring immediate surgical or radiation therapy in the opinion of the treating investigator and a radiation therapy or neurosurgical consultant).\n3. Extracranial disease is not required and if present, it can be measurable or non-measurable (RECIST v1.1).\n4. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 6 OR\n   2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 6 during the treatment period and for at least 120 days after the last dose of study treatment.\n5. A male patient must agree to use contraception as detailed in Appendix 6 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n6. The patient (or legally acceptable representative if applicable) provides written informed consent for the study.\n7. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 7).\n8. Has a life expectancy ≥12 weeks.\n9. Has adequate organ function within 28 days of study treatment initiation as defined below:\n\n   * Absolute neutrophil count ≥1000\u002FµL (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)\n   * Platelet count ≥100 000\u002FµL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n   * Hemoglobin ≥9.0 g\u002FdL\n   * Total bilirubin ≤1.5 × upper limit of normal (ULN); if hepatic metastases are present, ≤2.0 × ULN\n   * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × ULN; if hepatic metastases are present, ≤5.0 × ULN\n   * Creatinine clearance ≥50 mL\u002Fmin\n   * International normalized ratio (INR) OR prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN.\n10. Adequately controlled blood pressure with 0 or 1 antihypertensive medication (defined as blood pressure ≤150\u002F90 mmHg at screening and no changes in antihypertensive medication within 7 days of Day 1 of Cycle 1).\n11. Hepatitis B and C screening tests are not required unless:\n\n    * Known history of HBV or HCV infection\n    * As mandated by local health authority 11.1 Hepatitis B positive subjects\n    * Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n    * Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention\n\n11.2 Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\n• Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\nExclusion Criteria:\n\nPatients are excluded from the study if any of the following criteria apply, unless medically indicated and after approval by study chair\u002FIRB office:\n\n1. Has NSCLC with an oncogenic driver mutation (mutation\\[s\\] in EGFR, ERBB2, or BRAF V600E; fusion\u002Frearrangement\\[s\\] in ALK, ROS1, NTRK, or RET; or MET amplification). KRAS or PIK3CA mutation are allowed.\n2. Has hepatocellular carcinoma. NOTE: patients with hepatocellular carcinoma and brain metastasis are excluded from this trial because the dose of lenvatinib approved for this disease is different than the ones used in this trial.\n3. Has symptomatic or untreated spinal cord compression. Patients with clinical or radiographic evidence of leptomeningeal metastases or other metastatic systemic disease are not allowed. In cases where brain metastases are superficially located (cortical-based brain metastasis) and leptomeningeal spread is suspected, a work-up for leptomeningeal disease (LMD) should be performed (MRI and lumbar puncture with CSF cytology). If LMD is not confirmed, the treating physician, neuro-oncologist, or brain metastasis multidisciplinary team should make a clinical call and exclude the patient if LMD dissemination is likely.\n4. Has received prior therapy with lenvatinib or other antiangiogenic tyrosine kinase inhibitor alone or in combination with a PD-1\u002FPD-L1 inhibitor. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD L2, or anti-CTLA-4 agent or chemotherapy is allowed.\n5. Has received prior systemic anticancer therapy including investigational agents within 28 days prior to study treatment initiation.\n\n   * Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. Patients with immunotherapy-related AEs of a permanent nature but manageable (hypothyroidism on thyroid hormone replacement, vitiligo, etc.) are eligible.\n   * Patients must have recovered adequately from any complications from major surgery. Withhold lenvatinib treatment for at least 1 week prior to elective surgery. Do not administer lenvatinib for at least 2 weeks following major surgery and until adequate wound healing.\n6. Has received radiotherapy within 14 days prior to study treatment initiation. Patients must have recovered from all radiation-related toxicities, not require corticosteroids in dosing exceeding 10 mg daily of prednisone equivalent, and not have had radiation pneumonitis. Any radiation to the brain or spinal cord\u002Fcauda equina must have been completed within \\>3 weeks from study treatment initiation.\n7. Has received a live vaccine or live-attenuated vaccine within 30 days prior to study treatment initiation. Administration of killed vaccines is allowed.\n8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days or 5 half-lives, whichever is shorter, prior to study treatment initiation.\n\n   Note: Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 28 days after the last dose of the previous investigational agent.\n9. Contraindications to MRI (implanted metal device or foreign bodies) or MRI contrast (insufficient renal function or allergy).\n10. A WOCBP who has a positive screening serum pregnancy test within 7 days prior to Day 1 of Cycle 1 (see Appendix 6).\n11. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to study treatment initiation.\n12. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.\n\n    Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n13. Has severe hypersensitivity (≥ Grade 3) to pembrolizumab or lenvatinib and\u002For any of their excipients.\n14. Has a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment initiation. Inhaled or topical steroids, and adrenal replacement steroid doses ≤10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n15. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n16. Has an active infection requiring systemic therapy.\n17. Has a known history of human immunodeficiency virus.\n18. Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n\n    Note: Hepatitis B and C screening tests are not required unless:\n    * Known history of HBV and HCV infection\n    * As mandated by local health authority\n19. Active tuberculosis (Bacillus Tuberculosis).\n20. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n21. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n22. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.\n23. GI tract disease causing the inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis).\n24. Unable to swallow and retain oral medications.\n25. Has significant cardiac impairment including but not limited to history of congestive heart failure greater than New York Heart Association Class II (Appendix 8), unstable angina, myocardial infarction or stroke within previous 6 months, or cardiac arrhythmia requiring medical treatment at the time of screening.\n26. Has prolongation of QTc using Fridericia's formula (QTcF) to \\>480 ms.\n27. Has gastric or esophageal varices that may require treatment.\n28. Having a GI bleeding event or active hemoptysis (bright red blood of at least 0.5 teaspoon) with 28 days of enrollment.\n29. Has bleeding or thrombotic disorder(s) or uses anticoagulants such as warfarin or similar agents requiring therapeutic INR monitoring. Treatment with low molecular weight heparin is allowed.\n30. Electrolyte abnormalities that have not been corrected.\n31. Patients having \\>1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \\\u003C1 g\u002F24 hours.\n32. Has had an allogeneic tissue\u002Fsolid organ transplant.\n33. Has radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel.",{"count":532,"type":21},[51],"This is a single-center, open-label, multi-cohort Phase II study evaluating the efficacy and safety of pembrolizumab in combination with lenvatinib in patients with solid tumors and brain metastases.\n\nThe study will be comprised of 3 patient cohorts: triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), and solid tumor types other than TNBC and NSCLC. Cohort 3 will be comprised of solid tumor types with established (e.g., renal cell carcinoma \\[RCC\\], endometrial cancer) or preliminary clinical evidence (e.g., gastric cancer, colorectal cancer) of efficacy of programmed cell death-1 (PD-1) and angiogenesis inhibitors. The study will be conducted using a Simon's optimal two-stage design, and approximately 87 patients will be enrolled concurrently (n=29 per cohort).\n\nThe primary endpoint is intracranial objective response rate (ORR) as assessed by the modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.",[27,603],"Tumor",{"date":547,"type":32},{"date":606,"type":32},"2022-01-20",{"date":608,"type":21},"2028-02-28",{"name":592,"class":39},{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":22,"phases":617,"briefSummary":618,"conditions":619,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":627,"locationsCount":40},"100442963","phase-2-a-phase-ii-study-of-nivolumab-with-ipilimumab-and-cabozantinib-in-patients-with-untreated-renal-cell-carcinoma-brain-metastases-100442963","NCT05048212","A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases","Inclusion Criteria\n\n1. Signed Informed Consent Form (ICF)\n2. Ability and willingness to comply with the requirements of the study protocol\n3. Age ≥18 years\n4. Life expectancy \\>12 weeks\n5. Asymptomatic and off steroids for at least 10 days except patients: who have mild symptoms from intracranial disease that do not affect their performance status\n6. Prior therapies for extracranial metastatic renal cell carcinoma as long as it did not include anti- CTLA-4 or cabozantinib or MET inhibitors\n7. Patients with histologically confirmed metastatic renal cell carcinoma and at least one measurable intracranial target lesion for which all of the following criteria are met:\n\n   \\- Previously untreated or progressive after previous local therapy(limited to SRS and surgery)\n   * Immediate local therapy clinically not indicated or patient is not a suitable candidate to receive immediate local therapy.\n   * 5mm to 30mm, as determined by MRI with contrast.\n8. Adequate hematologic and essential organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (C1D1)\n\n   * Absolute neutrophil count (ANC) ≥1500 cells\u002FµL\n   * White blood cell (WBC) counts \\>2500\u002Fµ -- Lymphocyte count ≥500\u002FµL\n   * Platelet count ≥ 100,000\u002FµL;\n   * Hemoglobin ≥9.0 g\u002FdL\n   * Serum albumin≥2.8g\u002Fdl\n   * Total bilirubin ≤1.5×upper limit of normal (ULN) with the following exception:\n\n   Patients with known Gilbert disease who have serum bilirubin level ≤3×ULN may be enrolled.\n\n   \\- Alanine aminotransferase (ALT) ≤ 3x upper limit of normal (ULN).\n   * Aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN).\n   * Alkaline phosphatase ≤5×ULN in patients with documented bone metastases.\n   * Serum creatinine ≤ 1.5x ULN or calculated creatinine clearance ≥ 40mL\u002Fmin (≥ 0.675mL\u002Fsec) using the Cockcroft-Gault equation: Males: (140 - age) x weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72)Females: \\[(140 - age) x weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72)\\] × 0.85\n   * Urine protein\u002Fcreatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol), or 24-h urine protein ≤ 1 g.\n9. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and\u002For partner) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate \\[\\\u003C1% per year\\] when used consistently and correctly) and to continue its use for at least 12 months after the last dose of Cabozantinib and Nivolumab\n10. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 (see Appendix 5)\n11. INR and aPTT ≤1.5×ULN within 7 days prior to study enrollment 12. Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy.\n\nExclusion Criteria\n\n1. Symptomatic brain metastases requiring immediate local interventions such as craniotomy or SRS or whole brain radiation.\n2. Patients who require immediate surgical or radiotherapy interventions for extra-cranial lesions.\n3. Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n4. Requiring corticosteroid dose in 10 days prior to administration of first dose of study drug with following exceptions\n\n   \\- Symptomatic patients who have stable or decreasing corticosteroid use in the past 10 days may be included\n5. Patients with Leptomeningeal disease.\n6. Any approved anticancer therapy, including chemotherapy and hormonal therapy within 4 weeks prior to initiation of study treatment; however, the following are allowed:\n\n   * Hormone-replacement therapy or oral contraceptives\n   * Herbal therapy \\>1 week prior to Cycle 1, Day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to Cycle 1,Day 1)\n7. Current, recent (within 3 weeks of the first infusion of this study), or planned participation in an experimental drug study.\n8. AEs from prior anticancer therapy that have not resolved to Grade ≤1 except for alopecia.\n9. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; \\>Childes A cirrhosis; fatty liver; and inherited liver disease.\n10. Patients with acute leukemias, accelerated\u002Fblast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma.\n11. Patients who are pregnant, lactating, or breastfeeding.\n12. Known hypersensitivity to recombinant human antibodies.\n13. Inability to undergo MRI secondary to Metal implant and Gadolinium contrast allergy.\n14. Inability to comply with study and follow-up procedures.\n15. History of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome,\n\n    Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis with the following exception:\n    * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n    * Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible\n    * Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\n\n    Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\n    * Rash must cover less than 10% of body surface area (BSA), Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%).\n    * No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \\[PUVA\\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)\n16. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan with the following exception\n\n    -History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n17. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.\n18. History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C infection with the following exception:\n\n    * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive anti-HBc \\[antibody to hepatitis B core antigen\\] antibody test) are eligible.\n    * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n19. Active tuberculosis.\n20. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia\n21. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1.\n22. Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 with the following exception.\n\n    \\- Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.\n23. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live, attenuated vaccine will be required during the study\n\n    \\- Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to Cycle 1, Day 1 or at any time during the study and at least 5 months after last dose of nivolumab.\n24. Malignancies other than the disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score\n\n    ≤ 6, and prostate-specific antigen \\[PSA\\] ≤ 10 mg\u002FmL, etc.).\n25. Life expectancy of less than 12 weeks",{"count":508,"type":21},[51],"A Phase II Study of Nivolumab with Ipilimumab and Cabozantinib in Patients with Untreated Renal Cell Carcinoma Brain Metastases",[27,620],"Renal Cell Carcinoma","2026-04-07",{"date":623,"type":32},"2026-04-09",{"date":625,"type":32},"2022-09-20",{"date":278,"type":21},{"name":592,"class":39},{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":635,"enrollmentInfo":636,"targetDuration":4,"studyType":22,"phases":638,"briefSummary":639,"conditions":640,"keywords":642,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":40},"100534442","nitroglycerin-plus-radiotherapy-versus-conventional-radiotherapy-in-patients-with-lung-cancer-100534442","NCT06238882","Nitroglycerin Plus Radiotherapy Versus Conventional Radiotherapy in Patients With Lung Cancer.","A Phase III Study Comparing Concurrent Nitroglycerin With Radiation Therapy vs Radiation Therapy Alone in Patients With Non-small Cell Lung Cancer With EGFR Mutations and Brain Metastases.","Inclusion Criteria:\n\n* Patients diagnosed with advanced non-small cell lung cancer (which includes de novo stage IIIB-IV, according to the 8th edition AJCC, or recurrent disease), documented by histology and\u002For cytology.\n* Presence of brain metastases, candidates for treatment with holocranial radiation therapy.\n* Documented EGFR sensitivity mutation.\n* Disease measurable by criteria: The Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).\n* 18 years and up.\n* Functional status, by ECOG scale 0-2\n* Life expectancy at least 12 weeks.\n* Not receive vasodilator treatment as calcium channel blockers.\n* Electrocardiogram\n* Neutrophil count 1.5 x 103\u002Fmm3, platelet count \\>100 x (103\u002Fmm3).\n* Serum bilirubin should be 1.5 of the upper normal limit (ULN, upper normal limit).\n* AST and\u002For ALT 2 ULN (or 5 x ULN in patients with liver metastases).\n* Serum creatinine 1.5 (ULN), or creatinine clearance 60ml\u002Fmin.\n* Ability to comply with study and follow-up procedures.\n* Informed written (signed) consent to participate in the study.\n* Have tumor tissue (paraffin blocks from diagnostic biopsy) obtained before systemic treatment\n\nExclusion Criteria:\n\n* Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, ischemic heart disease, liver, kidney disease).\n* Patients with a history of allergy to glyceryl tinistate\n* Any other malignant pathology within the previous 5 years (except for cervical carcinoma in situ or basal-cell skin cancer, treated appropriately).\n* Pregnant and\u002For breastfeeding women.\n* Meningeal carcinomatosis corroborated by cytopathological study.\n\nDisposal Criteria:\n\n* Failure to follow protocol rules.\n* Loss of patient follow-up.\n* Patients who express their desire not to continue the study.\n* Patients with unacceptable toxicity","85 Years",{"count":637,"type":21},74,[98],"The goal of this interventional phase III clinical trial is to evaluate objective intracranial response rate (iORR) after a treatment with total cranial radiation therapy plus concomitant transdermal nitroglycerin (NTG) addition or total cranial radiation therapy only in patients with stage IV non-small cell lung cancer with brain metastases and EGFR mutation. The main questions it aims to answer are:\n\nDetermine progression-free survival (PFS) to CNS and overall survival (OS). Evaluate and compare the quality of life (QoL) of patients during and after treatment.\n\nEvaluate the cognitive function of patients before, during and after treatment. Evaluate treatment-associated toxicity to grade adverse treatment events Evaluation of HIF1α, VEGF and ROS1 in peripheral blood before and after nitroglycerin treatment.\n\nAll participants will have laboratory tests at the beginning and end of radiation therapy. Cranial MRI will be performed prior to treatment and 12 weeks after the end of treatment, then every 16 weeks until intracranial progression. Patients in the interventional group will be given 36 mg patches of transdermal nitroglycerin for 24 hours with a 12-hour rest interval during treatment with radiation therapy. The control group will only receive total cranial radiation therapy at the same doses and with the same schedule.",[132,27,641],"EGFR Gene Mutation",[643,644,390,645,646],"Radiation therapy","Nitroglycerin","EGFR mutation","Non-small cell lung cancer","2026-04-06",{"date":623,"type":32},{"date":650,"type":32},"2023-02-23",{"date":652,"type":21},"2027-02-15",{"name":654,"class":39},"Instituto Nacional de Cancerologia de Mexico",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":22,"phases":664,"briefSummary":665,"conditions":666,"keywords":671,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":676,"completionDateStruct":678,"leadSponsor":680,"locationsCount":64},"100629985","phase-3-bevacizumab-plus-fsrt-versus-hippocampus-avoidant-wbrt-in-lung-adenocarcinoma-with-extensive-brain-metastases-100629985","NCT07481786","Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases","Application of Bevacizumab Combined With Fractionated Stereotactic Radiotherapy (FSRT-Bev) Versus Hippocampus-Avoidant Whole-Brain Radiotherapy With Simultaneous Integrated Boost (HA-WBRT-SIB) in Patients With Extensive Brain Metastases From Lung Adenocarcinoma: A Phase III Randomized Controlled Trial Evaluating Intracranial Control Efficacy and Neurocognitive Function","Inclusion Criteria:\n\n* Age ≥18 years\n* Pathologically confirmed non-squamous non-small cell lung cancer (adenocarcinoma)\n* Extensive brain metastases meeting any of the following:\n\n1-2 metastases with at least one ≥3 cm in diameter; or 3-10 metastases with at least one ≥2 cm; or 11-20 metastases\n\n* Stable extracranial disease\n* ECOG performance status 0-2\n* Adequate bone marrow, hepatic, and renal function\n* Written informed consent\n\nExclusion Criteria:\n\n* Contraindications to bevacizumab (uncontrolled hypertension, history of bleeding\u002Fthromboembolism, recent surgery, etc.)\n* Leptomeningeal metastasis\n* Prior brain radiotherapy or surgical resection of brain metastases\n* Significant mass effect requiring urgent neurosurgical intervention\n* Severe cardiovascular, vascular, or gastrointestinal disease within 6 months\n* Proteinuria ≥3+ or 24-hour urine protein \\>1 g\n* Other active malignancies (except curable non-melanoma skin cancer or cervical carcinoma in situ)\n* Inability to comply with neurocognitive testing\n* Pregnancy or breastfeeding",{"count":663,"type":21},220,[270],"This is a phase 3, randomized, controlled clinical trial comparing two brain-directed treatment strategies for adult patients with extensive brain metastases from lung adenocarcinoma. The trial compares fractionated stereotactic radiotherapy combined with bevacizumab (FSRT-Bev) versus hippocampus-avoidant whole-brain radiotherapy with simultaneous integrated boost (HA-WBRT-SIB). The main objectives are to evaluate intracranial tumor control and preservation of neurocognitive function .\n\nPatients will be randomly assigned in a 1:1 ratio to receive either FSRT plus bevacizumab or HA-WBRT-SIB. In the experimental group, FSRT is delivered to visible brain tumors over 5 daily treatments (total 30 Gy, 6 Gy per fraction). Bevacizumab is given intravenously every 3 weeks for 4 cycles. In the control group, patients receive hippocampus-avoidant whole-brain radiation (25 Gy) with a simultaneous dose boost to metastatic lesions (40 Gy total) over 10 daily treatments.",[667,27,668,669,670],"Lung Adenocarcinoma","Radiotherapy, Intensity-Modulated","Bevacizumab","Whole-Brain Radiotherapy",[667,27,672,669,673],"fractionated stereotactic radiotherapy (FSRT)","Whole-brain radiotherapy with simultaneous integrated boost (HA-WBRT-SIB)","2026-04-03",{"date":647,"type":32},{"date":677,"type":32},"2026-03-20",{"date":679,"type":21},"2029-09-15",{"name":681,"class":39},"Sun Yat-sen University"]