[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586083":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":83,"centralContacts":36,"locations":87,"responsibleParty":120,"collaborators":122,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":36,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":36,"enrollmentInfo":135,"targetDuration":36,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":36,"overallStatus":89,"whyStopped":36,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (Photon-VMAT-CSI)","EXPERIMENTAL","Patients undergo photon-VMAT-CSI QD for 10 treatments over 10-20 days (Monday-Friday) in the absence of disease progression or unacceptable toxicity. Patients undergo MRI during screening and follow-up and undergo collection of blood samples throughout the trial. Patients also undergo LP or Ommaya reservoir tap for CSF sample collection during screening and follow-up.",[13,14,15,16,17,18,19,20],"Procedure: Biospecimen Collection","Radiation: Craniospinal Irradiation","Other: Electronic Health Record Review","Procedure: Lumbar Puncture","Procedure: Magnetic Resonance Imaging","Procedure: Ommaya Reservoir Tap","Other: Questionnaire Administration","Radiation: Volume Modulated Arc Therapy",[22,31,37,41,48,68,74,77],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Biospecimen Collection","Undergo blood and CSF sample collection",[9],[28,29,30],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"RADIATION","Craniospinal Irradiation","Undergo photon-VMAT-CSI",[9],null,{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Electronic Health Record Review","Ancillary studies",[9],{"type":23,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Lumbar Puncture","Undergo LP",[9],[46,47],"LP","Spinal Tap",{"type":23,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Magnetic Resonance Imaging","Undergo MRI",[9],[53,54,55,56,57,58,59,60,61,62,63,64,65,66,67],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":23,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Ommaya Reservoir Tap","Undergo Ommaya reservoir tap",[9],[73],"Ommaya Reservoir Access",{"type":6,"name":75,"description":39,"armGroupLabels":76,"otherNames":36},"Questionnaire Administration",[9],{"type":32,"name":78,"description":34,"armGroupLabels":79,"otherNames":80},"Volume Modulated Arc Therapy",[9],[81,82],"VMAT","Volumetric Modulated Arc Therapy (procedure)",[84],{"name":85,"affiliation":5,"role":86},"Stephanie M Yoon","PRINCIPAL_INVESTIGATOR",[88,108],{"facility":5,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"RECRUITING","Duarte","California","91010","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-117.97729,34.13945,{"lat":99,"lon":98},[102,107],{"name":103,"role":104,"phone":105,"phoneExt":36,"email":106},"Stephanie M. Yoon","CONTACT","626-873-5241","styoon@coh.org",{"name":103,"role":86,"phone":36,"phoneExt":36,"email":36},{"facility":109,"status":89,"city":110,"state":91,"zip":111,"country":93,"countryCode":94,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"City of Hope at Irvine Lennar","Irvine","92618",{"type":96,"coordinates":113},[114,115],-117.82311,33.66946,{"lat":115,"lon":114},[118,119],{"name":103,"role":104,"phone":105,"phoneExt":36,"email":106},{"name":103,"role":86,"phone":36,"phoneExt":36,"email":36},{"type":121,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[123],{"name":124,"class":125},"National Cancer Institute (NCI)","NIH","100586083","phase-2-photon-craniospinal-irradiation-for-the-treatment-of-leptomeningeal-disease-secondary-to-breast-cancer-or-non-small-cell-lung-cancer-100586083",false,"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)","ALL","18 Years",{"count":136,"type":137},35,"ESTIMATED","INTERVENTIONAL",[140],"PHASE2","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.",[143,144,145,146,147],"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","2025-12-02",{"date":150,"type":151},"2025-12-08","ACTUAL",{"date":153,"type":151},"2025-05-05",{"date":155,"type":137},"2028-10-02",{"name":5,"class":6},2]