[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556413":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":33,"studyPopulation":25,"armGroups":34,"interventions":41,"overallOfficials":25,"centralContacts":45,"locations":25,"responsibleParty":55,"collaborators":25,"id":59,"slug":25,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":25},{"fullName":5,"class":6},"Shanghai Jiao Tong University Affiliated Sixth People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"progression-free survival","6 months of progression-free survival","6 months",[14,17,19,22],{"measure":10,"description":15,"timeFrame":16},"12 months progression-free survival","12 months",{"measure":10,"description":18,"timeFrame":16},"12 months of progression-free survival",{"measure":20,"description":21,"timeFrame":16},"OS","12 months of OS",{"measure":23,"description":24,"timeFrame":16},"Adverse reactions related to radiotherapy","Adverse reactions",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"NA","SINGLE_GROUP","Single dose high-dose （10Gy）implantable brachytherapy","TREATMENT",{"masking":32,"maskingDescription":25,"whoMasked":25},"NONE","Screening period: Local MRI or CT examination, blood routine and coagulation function test.\n\nSelected treatment period: All enrolled patients received one dose of close range interstitial radiotherapy with a radiation dose of 10 Gy. The number of insertion needles depends on the size and location of the tumor. The instrument used for radiotherapy is the Medda high-dose rate brachytherapy machine, and the radiation source is 192 iridium. Record treatment related acute events such as bleeding during the treatment period.\n\nFollow up: Follow up with local MRI or CT at 1 month, 3 months, 6 months, and 1 year after the end of radiotherapy treatment to evaluate the treatment effect; Simultaneously follow up with patients for survival and treatment related adverse reactions, such as dermatitis, infections, etc.",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"brachytherapy","EXPERIMENTAL","Patients with locally unresectable giant osteosarcoma masses who meet the criteria are enrolled in the experimental group, and all patients receive a single dose of 10Gy of implantable brachytherapy. Record treatment-related acute events during and after treatment. Follow up on survival and local control after treatment ends, marking the end of the trial treatment.",[40],"Radiation: brachytherapy",[42],{"type":43,"name":36,"description":38,"armGroupLabels":44,"otherNames":25},"RADIATION",[36],[46,51],{"name":47,"role":48,"phone":49,"phoneExt":25,"email":50},"Xiaojing Yang, Dr","CONTACT","86-21-2405-8972","yangxj717@163.com",{"name":52,"role":48,"phone":53,"phoneExt":25,"email":54},"Jie Fu, Dr","86 21 24058973","fujie74@sjtu.edu.cn",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Xiaojing Yang","Principal Investigator","100556413",false,"NCT06524778","Single High-dose Brachytherapy for Giant Osteosarcoma Masses","The Therapeutic Effect of Single High-dose Brachytherapy for Locally Inoperable and Metastatic Giant Osteosarcoma Masses","Inclusion Criteria:\n\n1. Pathological diagnosis of osteosarcoma;\n2. Age range 12-70 years old;\n3. The primary or metastatic lesion cannot be surgically removed based on clinical evaluation, and treatment with internal medicine multi line chemotherapy, targeted therapy, immunotherapy, etc. is ineffective;\n4. ECOG physical fitness status is 0-1 points;\n5. According to RECIST version 1.1 standard, there must be at least one evaluable target lesion with a mass length diameter greater than 5cm;\n6. Sign a written informed consent form before conducting any experimental activities;\n7. Researchers determine that they are able to comply with the research protocol;\n8. Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests, and other research procedures.\n\nExclusion Criteria:\n\n1. Local mass previously received radiation therapy;\n2. Major surgery ≤ 4 weeks before enrollment;\n3. Previous or concurrent malignant tumors (excluding malignant tumors that have been cured and have a cancer free survival of more than 5 years, such as basal cell carcinoma of the skin and papillary thyroid carcinoma);\n4. Pregnant or lactating women;\n5. Active pulmonary tuberculosis.","ALL","12 Years","70 Years",{"count":69,"type":70},16,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This study is a prospective, single-arm, phase II, single-center study. Patients with locally unresectable giant osteosarcoma masses who meet the criteria are enrolled in the experimental group, and all patients receive a single dose of 10Gy of implantable brachytherapy. Record treatment-related acute events during and after treatment. Follow up on survival and local control after treatment ends, marking the end of the trial treatment.",[76],"Osteosarcoma",[36,78,79],"high-dose","osteosarcoma","NOT_YET_RECRUITING","2024-08-05",{"date":83,"type":84},"2024-08-07","ACTUAL",{"date":86,"type":70},"2024-08-30",{"date":88,"type":70},"2027-06-30",{"name":5,"class":6}]