[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471844":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":27,"locations":37,"responsibleParty":55,"collaborators":20,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":20,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Shanghai Proton and Heavy Ion Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with locally advanced unresectable pancreatic cancer","EXPERIMENTAL","Patients with locally advanced unresectable pancreatic cancer without invasion of the gastrointestinal tract, cT4N0-2M0 Stage III (AJCC\u002FUICC Version 8).",[13],"Radiation: Carbon ion radiotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Carbon ion radiotherapy","Patients with locally advanced unresectable pancreatic cancer without invasion of gastrointestinal tract will received ablative carbon ion radiotherapy. The prescription dose for primary pancreatic lesion, positive lymph node, and retroperitoneal high-risk recurrence area is 67.5 Gy (RBE weighted dose) in 15 fractions for 3 weeks; Pancreatic primary lesion and positive lymph node SIB to 75 Gy (RBE weighted dose) in 15 fractions for 3 weeks.",[9],null,[22,25],{"name":23,"affiliation":5,"role":24},"Zheng Wang, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":5,"role":24},"Xin Cai, MD",[28,33],{"name":23,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","+86-02138296666","53407","zheng.wang@sphic.org.cn",{"name":34,"role":29,"phone":35,"phoneExt":20,"email":36},"Guo-Liang Jiang, MD","+86-02138296606","guoliang.jiang@sphic.org.cn",[38],{"facility":5,"status":39,"city":40,"state":20,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Shanghai","201315","China","CN",{"type":45,"coordinates":46},"Point",[47,48],121.45806,31.22222,{"lat":48,"lon":47},[51,53],{"name":52,"role":29,"phone":30,"phoneExt":31,"email":32},"Zheng Wang, MD",{"name":34,"role":29,"phone":54,"phoneExt":20,"email":36},"8621 38296606",{"type":24,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Guoliang Jiang","Principal Investigator","100471844","ablative-carbon-ion-radiotherapy-with-pencil-beam-scanning-for-locally-advanced-unresectable-pancreatic-cancer-100471844",false,"NCT05424159","Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning for Locally Advanced Unresectable Pancreatic Cancer","Prospective Phase II Clinical Trial of Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning Using Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer","Inclusion Criteria:\n\n1. Have the ability to sign the written informed consent;\n2. Ductal adenocarcinoma of the pancreas confirmed by histopathology or cytopathology;\n3. Distant metastasis was excluded by imaging assessment (PET-CT, cranial MRI), and was defined as locally advanced unresectable according to NCCN Guidelines Version 2022.1, that is, T4N0-2M0, Stage III (AJCC\u002FUICC Version 8);\n4. The maximum diameter of pancreatic primary lesion and positive lymph node ≤7cm;\n5. Pancreas primary lesion or positive lymph node did not invade digestive tract (stomach, duodenum and small intestine);\n6. Eastern Cooperative Oncology Group (ECOG) performance score 0-1;\n7. Adequate bone marrow function (neutrophil count ≥1.5×109\u002FL, platelet count ≥100×109\u002FL, hemoglobin ≥10.0g\u002FdL);\n8. Adequate liver function (total bilirubin \\\u003C1.5 times the upper limit of normal value, aminotransferase \\\u003C2.5 times the upper limit of normal value);\n9. Adequate renal function (serum creatinine \\\u003C2mg\u002FdL, or creatinine clearance \\>50mL\u002Fmin).\n\nExclusion Criteria:\n\n1. Multiple primary pancreatic lesions (\\>1);\n2. Tumor invaded the adjacent digestive tract;\n3. Radiation therapy history;\n4. Other local treatments history for pancreatic cancer, such as HIFU and irreversible electroporation;\n5. The irradiation dose of organs at risk cannot reach the dose constraint;\n6. Other malignant tumors history;\n7. Inability to understand the purpose of treatment or unwillingness\u002Finability to sign informed consent.","ALL","18 Years","80 Years",{"count":69,"type":70},48,"ESTIMATED","INTERVENTIONAL",[73],"NA","The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer with pencil beam scanning and simultaneous integrated boost (SIB) technology.",[76],"Pancreatic Cancer Non-resectable",[78,17,79,80,81],"Locally advanced unresectable pancreatic cancer","Phase II clinical trial","Ablative dose","Optimized linear energy transfer","2023-11-30",{"date":84,"type":85},"2023-12-07","ACTUAL",{"date":87,"type":85},"2022-07-01",{"date":89,"type":70},"2026-12",{"name":5,"class":6},1]