[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-malignant-neoplasm-in-the-leptomeninges\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-malignant-neoplasm-in-the-leptomeninges":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,67,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100554545","phase-3-testing-proton-craniospinal-radiation-therapy-versus-the-usual-radiation-therapy-for-leptomeningeal-metastasis-radiate-lm-trial-100554545",false,"NCT06500481","Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial","A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (Radiate-LM)","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION\n* Patients with pathologically (histologically or cytologically) proven diagnosis of breast cancer or NSCLC\n* Patients must have newly diagnosed leptomeningeal metastasis established through at least one of the following:\n\n  * Positive CSF cytology for malignancy\n\n    * CSF cytology with suspicious cells is considered positive; CSF cytology with atypical cells is considered equivocal and not positive\n  * Patients with an equivocal or negative CSF cytology result, or not suitable for CSF sampling, radiographic diagnosis of leptomeningeal metastasis with linear and\u002For nodular disease and documentation of typical clinical signs (European Association of Neuro-Oncology \\[EANO\\]-European Society for Medical Oncology \\[ESMO\\] Diagnostic Criteria Type IIA-IIC) is required\n\n    * Patients with typical clinical signs of leptomeningeal metastasis may have one or more of the following symptoms and signs: headache, nausea, vomiting, mental status change, gait difficulty, cranial nerve palsy, diplopia, visual change, hearing loss, radicular weakness, radicular sensory change, urinary retention, saddle anesthesia, constipation, neck pain, and back pain\n  * For patients with prior history of immunotherapy or current immunotherapy, CSF sampling rather than just MRI enhancement is strongly recommended to exclude immune-related aseptic meningitis\n* Patients must be candidates for radiation therapy for the treatment of leptomeningeal metastasis\n* Age ≥ 18\n* PRIOR TO STEP 2 REGISTRATION\n* Note: Step 2 registration must occur no later than 30 calendar days after step 1 registration\n* Financial clearance for proton therapy treatment\n* Patients must have systemic disease evaluation through standard of care imaging for example CT chest\u002Fabdomen\u002Fpelvis or body PET\u002FCT\n* Karnofsky performance status ≥ 60\n* Not pregnant and not nursing\n\n  * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* Hemoglobin ≥ 8.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] ≥ 8.0 g\u002Fdl is acceptable)\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3 (Note: the use of granulocyte-colony stimulating factor or other intervention to achieve ANC ≥ 1,000\u002Fmm\\^3 is acceptable)\n* Platelets ≥ 100,000\u002Fmm\\^3 (Note: the use of transfusion or other intervention to achieve platelets ≥ 100,000\u002Fmm\\^3 is acceptable)\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (patients with known Gilbert disease without other clinically significant liver abnormalities are not excluded)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine transaminase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × ULN\n* No prior radiation therapy to the spinal cord with equivalent dose in 2 gray (Gy) fractions (EQD2) more than 40Gy or cauda equina with EQD2 more than 50Gy using alpha\u002Fbeta ratio of 3\n* No prior treatment for leptomeningeal metastasis (note: prior CNS treatment for other non-leptomeningeal disease is allowed)\n* No history of unstable angina requiring hospitalization in the last 3 months\n* No history of myocardial infarction within the last 3 months\n* New York Heart Association Functional Classification II or better (New York Heart Association \\[NYHA\\] Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n* No active infection currently requiring intravenous (IV) antibiotic management\n* No active chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy\n* No CTCAE v5.0 ≥ grade 2 encephalopathy","ALL","18 Years",{"count":19,"type":20},115,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This phase III trial compares proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis). Patients with leptomeningeal metastasis (LM) may develop multiple areas of nervous system (neurologic) impairment that can be life-threatening. Radiation therapy (RT) effectively relieves local symptoms due to LM. RT uses high energy radiography (x-rays), particles, or radioactive seeds to kill cancer cells and shrink tumors. IFRT is commonly used to treat symptoms of LM. IFRT is radiation treatment that uses x-rays to treat specific areas of LM and to relieve and\u002For prevent symptoms. pCSI uses protons that can be directed with more accuracy than x-rays which allows treatment of the entire central nervous system space containing the cerebrospinal fluid (CSF), brain, and spinal cord. The pCSI treatment could delay the worsening of LM. Giving pCSI may be better than IFRT in treating LM in patients with breast or non-small cell lung cancer.",[26,27,28,29,30],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Neoplasm in the Leptomeninges","Stage IV Lung Cancer AJCC v8","RECRUITING","2026-06-22",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":35},"2025-03-04",{"date":39,"type":20},"2028-07-31",{"name":41,"class":42},"NRG Oncology","OTHER",58,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100555897","phase-2-hippocampal-avoidance-in-craniospinal-irradiation-for-the-treatment-of-leptomeningeal-metastases-from-breast-cancer-or-non-small-cell-lung-cancer-100555897","NCT06518057","Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer","A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors","Inclusion Criteria:\n\n* Patients with breast cancer or NSCLC malignancies with leptomeningeal metastases established radiographically and\u002For through CSF cytology\n* Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases\n* Patients ≥ 18 years old\n* Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) ≥ 2\n* The patient is able to provide informed consent\n* Hemoglobin \\> 8 g\u002FdL\n* Absolute neutrophil count \\> 1,000\u002Fmm\n* Platelet count \\> 100,000\u002Fmm\n* Participants born female at birth must either be of non-reproductive potential (i.e. post-menopausal by history \\[≥ 60 years old, or with no menses for \\> 1 year without an alternative medical cause\\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum \u002Furine pregnancy test within 3 weeks prior to starting radiation therapy (RT)\n* Patients with reproductive potential must agree to practice two highly effective contraceptive methods\n\nExclusion Criteria:\n\n* Patients with multiple, serious major neurologic deficits per physician\u002Finvestigator assessment including encephalopathy\n* Patients with extensive systemic disease and without reasonable systemic treatment options\n* Patients who are unable to undergo MRI brain and spine with gadolinium contrast\n* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances\n* Gross ventricular disease\n* Brain metastases within 5 mm of the hippocampal contours not previously treated\n* Pregnant or lactating women",{"count":52,"type":20},22,[54],"PHASE2","This phase II clinical trial studies how well craniospinal irradiation (CSI) with hippocampal avoidance, using proton therapy or volumetric modulated arc therapy (VMAT), works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid (CSF) and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal metastases). Radiation therapy is an effective treatment in relieving localized symptoms caused by leptomeningeal metastases. However, the type of radiation therapy typically used does not prevent the spread of leptomeningeal disease. CSI (radiation therapy directed at the brain and spinal cord to kill tumor cells) may be able to target all of the areas of possible leptomeningeal tumor spread. CSI may however result in significant neurological side effects due to radiation damage to a part of the brain called the hippocampus. Hippocampal avoidance (HA) reduces the amount of radiation to the hippocampus. Proton or VMAT CSI with HA may be an effective treatment while reducing neurological side effects for patients with leptomeningeal metastases from breast cancer and NSCLC.",[26,27,28,29,30],"2026-06-15",{"date":59,"type":35},"2026-06-17",{"date":61,"type":35},"2025-03-03",{"date":63,"type":20},"2028-07-01",{"name":65,"class":42},"University of Washington",2,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100496599","tumor-treating-fields-for-the-treatment-of-leptomeningeal-metastases-of-the-spine-in-patients-with-breast-or-lung-cancer-100496599","NCT05746325","Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer","Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases Involving the Spine","Inclusion Criteria:\n\n* Age \\>= 18\n* Prior tissue diagnosis of breast cancer or lung cancer\n* Confirmed diagnosis of leptomeningeal metastases (LM) with positive cerebrospinal fluid (CSF) cytology for malignancy and meningeal enhancement (type 1A, 1B, and 1C)\n* Radiographic evidence on MRI of leptomeningeal enhancement within the cervical, thoracic or lumbar spine on spinal MRI\n* Life expectancy of at least 6 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3\n* Recovery from any neurotoxic effects of prior therapy\n* Platelet count greater than 25 x 10\\^9\u002FL\n* Absolute neutrophil count (ANC) greater than 0.5 x 10\\^9\u002FL\n* Patients must have adequate liver function, total bilirubin \\\u003C 2.5 mg\u002FdL, unless elevated total bilirubin is due to elevated indirect bilirubin from known Gilbert's disease, aspartate aminotransferase (AST) =\\\u003C 3.5 times upper limits of normal; adequate renal function \\[calculated estimated glomerular filtration rate (eGFR) \\>= 30 mL\u002Fmin\u002F body surface area (BSA)\\]\n* Patients or legal medical representative must provide written informed consent\n* Patients must have suitable body habitus for placement of transducer arrays\n* Patients must be willing to wear the device for at least 18 hours a day (averaged over monthly)\n* Patients must be willing to return for the scheduled evaluations and perform the required assessments\n* Patients are without other disease or situation which would significantly compromise adequate assessment of safety and feasibility of the TTF\n* Patient willing to start a study treatment with TTF =\\\u003C 14 days from registration\n\nExclusion Criteria:\n\n* Concomitant therapy:\n\n  * Must not be receiving concurrent high-dose methotrexate (\\>= 3 g\u002Fm\\^2), high dose thiotepa, or high-dose cytarabine (\\>= 3 g\u002Fm\\^2). Any other systemic chemotherapy, targeted treatment, hormonal or immunotherapy directed at the primary systemic malignancy is permitted\n  * Must not have received radiation therapy (RT) to the brain or spinal cord within 2 weeks of initiation of TTF\n  * Must be at least 1 week from cessation of any prior intrathecal chemotherapy\n* Women of childbearing age who are pregnant or lactating. (Male and female patients who are fertile must be willing to use an effective means of birth control to avoid pregnancy)\n* Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (HIV)\n* Patients receiving any other investigational agents and must not have received any other investigational agent within 14 days prior to registration. The 14-day period should be extended if the investigational agent is known to have delayed toxicity\n* Patients known to be allergic to the hydrophilic gel utilized for transducer attachment\n* Patients with surgical hardware within the planned area of treatment in the spine (e.g., titanium rods, screws, fixation devices)",{"count":75,"type":20},5,[77],"NA","This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.",[26,27,29,80,30],"Metastatic Lung Carcinoma","2026-03-31",{"date":83,"type":35},"2026-04-02",{"date":85,"type":35},"2023-04-07",{"date":87,"type":20},"2027-03-01",{"name":89,"class":42},"Mayo Clinic",1,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":66},"100586083","phase-2-photon-craniospinal-irradiation-for-the-treatment-of-leptomeningeal-disease-secondary-to-breast-cancer-or-non-small-cell-lung-cancer-100586083","NCT06910761","Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer","Phase II Trial of Photon Craniospinal Irradiation for Leptomeningeal Disease Secondary to Solid Tumor Malignancy","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* ≥ 18 years\n* Karnofsky performance status (KPS) ≥ 60\n* Ability to read and understand English or Spanish for questionnaires, or ability to complete questionnaires using certified interpreter\n* Histologically confirmed breast cancer or non-small cell lung cancer\n* Leptomeningeal disease established either radiographically and\u002For CSF cytology\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n* Hemoglobin ≥ 8 g\u002FdL\n* Platelet ≥ 100,000\u002Fmm\\^3\n* Creatinine clearance of ≥ 50 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Chemotherapy, biological therapy, immunotherapy within 7 days prior to day 1 of protocol therapy\n* Any prior radiation that in the opinion of the investigator unable to respect normal tissue tolerances and preclude craniospinal irradiation\n* Patients with multiple or serious major neurologic symptoms (including encephalopathy) per physician \u002F investigator assessment\n* Patients with extensive, uncontrolled extracranial systemic disease\n* Patients without reasonable systemic treatment options per physician \u002F investigator\n* Other clinically significant uncontrolled illness per opinion of physician \u002F investigator\n* Patients with a history or evidence of HIV infection (unless on effective anti-retroviral therapy with undetectable viral load based on prior tests within 6 months are eligible for this trial)\n* Patients with history or evidence of chronic hepatitis B virus (HBV) infection (unless HBV viral load is undetectable based on prior tests and on suppressive therapy)\n* Patients with a history or evidence of hepatitis C virus (HCV) infection unless treated and cured. (Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load based on prior tests)\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Unable to undergo MRI brain and spine with gadolinium contrast\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":99,"type":20},35,[54],"This phase II trial tests how well craniospinal irradiation (CSI) using photon volumetric modulated arc radiotherapy (VMAT) works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal disease). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. CSI (radiation therapy directed at the brain and spinal cord to kill tumor cells) may be able to target all of the areas of possible leptomeningeal tumor spread. Photon-VMAT-CSI may be an effective treatment option for patients with leptomeningeal disease secondary to breast cancer or NSCLC.",[26,27,28,29,30],"2025-12-02",{"date":105,"type":35},"2025-12-08",{"date":107,"type":35},"2025-05-05",{"date":109,"type":20},"2028-10-02",{"name":111,"class":42},"City of Hope Medical Center"]