[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stereotactic-radiotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stereotactic-radiotherapy":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100551270","phase-3-srssrthypo-rt-versus-ha-wbrt-for-no-more-than-10-brain-metastases-in-sclc-100551270",false,"NCT06457906","SRS\u002FSRT\u002FHypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC","SRS\u002FSRT\u002FHypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in Patients With Small-Cell Lung Cancer: A Prospective, Randomized, Multicenter Phase III Trial (SHARP Trial)","SHARP","Inclusion Criteria:\n\nInvestigators should consider these factors when selecting patients for this trial. Investigators also should consider all other relevant factors (medical and non-medical), as well as the risks and benefits of the study therapy, when deciding if a patient is an appropriate candidate for this trial.\n\n1. Adult patients (18-80 years of age) with Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance score ≥ 70, expected life time more than 6 months;\n2. Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis). Patients with de novo or recurrent small cell lung cancer are permitted;\n3. No more than 10 metastatic brain lesions with ≤5 cm in largest diameter and ≤150 ml in treated volume, confirmed by a high-resolution (thickness ≤2mm) , 3-dimensional T1-weighted postgadolinium magnetic resonance imaging (MRI) brain scan within 2 weeks of study initiation. All brain metastases must be outside a 5-mm margin around either hippocampus or optic pathways.\n4. Not all metastatic brain lesions are recommended or suitable for surgical resection after multidisciplinary team discussion. If part of metastatic brain lesions are resected, the patient is permitted for enrollment evaluation at least two weeks after resection; 5 Patients must have the psychological ability and general health that permits completion of the study requirements, all assessment (HVLT-R, MoCA, EORTC QLQ-C30) and required follow up (at least 6 months);\n\n6\\. At least one measurable BM according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria; 7. Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception during treatment on this study and for up to 180 days after completion of all treatment to prevent pregnancy or fathering a child; 8. Written informed consent (must be available before enrolment in the trial).\n\nExclusion Criteria:\n\n1. Clinical or radiologic evidence of new, untreated, and\u002For progressive brain metastases prior to registration;\n2. Previous radiotherapy of the brain;\n3. Patients can not tolerate immobilization or are with MRI contraindication (i.e., cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants);\n4. Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, leptomeningeal metastases, increased intracranial pressure requiring immediate depression surgery.\n5. Patients who have not yet recovered from acute high-grade (≥Grade 3) toxicities of prior therapies according Common Terminology Criteria for Adverse EventsVersion5.0 (CTC 5.0);\n6. Presence of other serious illnesses such as acute myocardial infarction, severe arrhythmia, or psychiatric disorders within the past 6 months;\n7. Known carcinoma \\\u003C 5 years ago (excluding carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy;\n8. Pregnant or lactating women;\n9. Participation in another clinical study or observation period of competing trials, respectively;","ALL","18 Years","80 Years",{"count":21,"type":22},340,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This phase III trial compares the effect of stereotactic radiosurgery and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain.",[28,29,30,31,32,33],"Small-cell Lung Cancer","Brain Metastases","SRS","Stereotactic Radiotherapy","Whole Brain Radiotherpay","Hippocampal-avoidance",[28,29,30,35,36,37,33],"Stereotactic radiotherapy","Whole brain radiotherpay","Hypofractionaed radiotherapy","RECRUITING","2025-07-12",{"date":41,"type":42},"2025-07-16","ACTUAL",{"date":44,"type":42},"2023-09-01",{"date":46,"type":22},"2028-02-28",{"name":48,"class":49},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":50},"100533850","a-feasibility-study-of-ihd-srt-for-bm-100533850","NCT06231186","a Feasibility Study of iHD-SRT for BM","Isotoxic High Dose (iHD) Fractionated Stereotactic Radiation Therapy (fSRT) for Intact Brain Metastases : a Feasibility Study","Inclusion Criteria:\n\n* Ability to understand and willingness to participate the research and sign the consent form\n* ECOG PS 0-2\n* The primary or metastatic lesion was confirmed by pathological histology as a malignant tumor\n* Head MRI diagnosis of brain metastasis with measurable lesions and technically feasible SRT (no more than 15 in number and 20cc in volume)\n* Estimated survival time ≥ 3 months\n\nExclusion Criteria:\n\n* Diffuse brain metastases, or combined with meningeal metastases, or technically difficult to perform SRT\n* With severe internal medicine complications or absolute contraindications for radiotherapy\n* other sufficient reasons to be unqualified, such as potential non-compliance with the clinical protocol, etc",{"count":59,"type":22},35,[61],"NA","Brain metastasis is the most challenging disease in the field of tumor treatment, with a median overall survival of only 1-2 months for untreated patients. Stereotactic radiotherapy (SRT) has the advantages of precise positioning, relatively concentrated dosage, shorter course, and lower toxicity. Several studies could effectively protect cognitive function and achieve better tumor control rate. Currently, it has gradually replaced WBRT as standard local treatment choice for brain metastases. SRT includes Stereotactic Radiosurgery (SRS) and Fractional Stereotactic Radiotherapy (fSRT). With the continuous updating of domestic radiation therapy equipment, the use of high-resolution multi leaf gratings enables the accuracy of fSRT based on linear accelerators to reach 0.5mm or even lower levels, and has gradually become one of the main choices for local treatment of a limited number of patients with brain metastases.\n\nHowever, there is currently no prospective randomized controlled study data analyzing the clinical benefits of different segmentation and dosages of SRT. In retrospective data comparing different segmentation schemes, researchers found that higher BED was associated with better local control. However, the ASTRO guidelines recommend relatively conservative doses for SRT of brain metastases, especially as the lesion volume increases, and the recommended dose of BED10 for SRT was only 48 Gy (30 Gy\u002F5 Fx). This is based on the consideration that higher radiation exposure will bring a higher risk of radiation-induced brain necrosis. However, with the continuous updates of SRT treatment equipment and technology, existing technologies can achieve higher dose coverage for more brain metastases while meeting the normal tissue limit. Therefore, this study conducted a prospective intervention study to explore the feasibility and safety of optimizing SRT dosage based on normal tissue tolerance for the treatment of brain metastases, in order to further improve the therapeutic effect of intracranial lesions with brain metastases.\n\nThis study is designed as a single arm open prospective study, assuming that under this treatment regimen, the proportion of patients with lesion prescription dose BED10\\>50 Gy is 90%, and the incidence of radiation-induced brain necrosis within 1 year is 8.5%. The planned enrollment period is 2 years and follow-up period is 1 year. A total of 35 people need to be enrolled.",[64,31],"Brain Metastases, Adult","2024-04-08",{"date":67,"type":42},"2024-04-10",{"date":69,"type":42},"2024-03-15",{"date":71,"type":22},"2026-12",{"name":73,"class":49},"Ruijin Hospital",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":81,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":50},"100528832","phase-2-stereotactic-radiotherapy-combined-with-adebrelimab-and-tcb-nab-paclitaxel--carboplatin-in-neoadjuvant-treatment-of-tnbc-100528832","NCT06165900","Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC","A Multicenter, Randomized Trial of Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) Versus Adebrelimab Combined With TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of Triple-negative Breast Cancer","Inclusion Criteria:\n\n* Treatment-naïve breast cancer female patients aged ≥ 18 years and ≤ 75 years;\n* Histopathologically confirmed early or locally advanced triple-negative invasive breast cancer according to the latest ASCO\u002FCAP guidelines, meeting the following conditions: (1) pathological type is triple-negative, specifically: ER negative: IHC \\\u003C 1%, PR negative: IHC \\\u003C 1%, HER2 negative: IHC 0\u002F1 + or IHC2 + but ISH negative;\n* Clinical stage II-III invasive breast cancer with measurable lesions according to RECIST 1.1;\n* ECOG score 0-1;\n* Able to tolerate preoperative and postoperative adjuvant radiotherapy after assessment by a radiologist;\n* Appropriate level of organ function\n* Patients voluntarily participate in and sign the informed consent form, are expected to have good compliance and cooperate with the study according to the requirements of the protocol.\n\nExclusion Criteria:\n\n* Patients with metastatic breast cancer or bilateral breast cancer;\n* Patients with inflammatory breast cancer or occult breast cancer;\n* Patients received any anti-tumor therapy within 12 months before signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy or tumor embolization;\n* Patients previously received PD-1\u002FPD-L1 antibody, CTLA-4 antibody, or other treatments against PD-1\u002FPD-L1 inhibitors;\n* Female patients who are pregnant and lactating, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial.\n* Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic drug abuse, alcoholism ;\n* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) test, or positive hepatitis B core antibody (HBcAb) test followed by positive HBV-DNA test (HBV-DNA test was performed only in patients with negative HBsAg test and positive HBcAb test); positive hepatitis C virus (HCV) antibody test followed by positive HCV-RNA test (HCV-RNA test was performed only in patients with positive HCV antibody test)\n* Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.","FEMALE","75 Years",{"count":84,"type":22},136,[86],"PHASE2","This study was an open-label, multicenter, randomized study. It is planned to include 136 patients with stage II-III triple negative breast cancer. Eligible subjects will be randomized to receive either the experimental arm: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) or the control arm: adebrelimab plus nab-paclitaxel + carboplatin.",[31,89,90],"Immunotherapy","Breast Cancer","2024-01-02",{"date":93,"type":42},"2024-01-03",{"date":95,"type":42},"2023-09-26",{"date":97,"type":22},"2028-12-15",{"name":99,"class":49},"Shengjing Hospital"]