[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612741":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":18,"locations":19,"responsibleParty":37,"collaborators":18,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":18,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":18,"enrollmentInfo":48,"targetDuration":18,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":18,"overallStatus":22,"whyStopped":18,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},{"fullName":5,"class":6},"Yonsei University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Carbon Ion Radiotherapy","EXPERIMENTAL","Participants receive carbon ion radiotherapy delivered either as 55.2 Gy in 12 fractions over 3 weeks or 40-48 Gy in 4 fractions over 1 week. Treatment planning includes 4D-CT-based simulation, defined target volumes (GTV\u002FCTV), and organ-at-risk dose constraints. Radiotherapy is administered with daily or alternate-day fractionation depending on the selected regimen.",[13],"Other: Carbon Ion Radiotherapy",[15],{"type":6,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"Carbon ion radiotherapy is delivered with two possible regimens: 55.2 Gy in 12 fractions over 3 weeks or 40-48 Gy in 4 fractions over 1 week. Treatment planning is performed using contrast-enhanced CT and 4D-CT to assess respiratory motion. Target volumes include the gross tumor volume and high-risk peripancreatic regions, while organs at risk (stomach, duodenum, bowel, liver, kidneys, spinal cord) follow strict dose constraints. Treatments are delivered once daily for the 12-fraction regimen or on alternate days for the 4-fraction regimen. Adaptive planning may be applied if weekly evaluation CT identifies anatomic changes. Acute and late toxicities are monitored throughout treatment using CTCAE v5.0.",[9],null,[20],{"facility":21,"status":22,"city":23,"state":18,"zip":18,"country":24,"countryCode":18,"cosmosGeoPoint":25,"geoPoint":30,"contacts":31},"Yonsei University Health System, Severance Hospital","RECRUITING","Seoul","South Korea",{"type":26,"coordinates":27},"Point",[28,29],126.9784,37.566,{"lat":29,"lon":28},[32],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Ik Jae Lee","CONTACT","+82-2-2228-8117","IKJAE412@YUHS.AC",{"type":38,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100612741","phase-2-carbon-ion-radiotherapy-in-frail-patients-with-pancreatic-cancer-100612741",false,"NCT07257523","Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer","Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer: A Prospective Phase II Study","Inclusion Criteria:\n\n\\- Histologically confirmed pancreatic cancer without distant metastasis.\n\nNot eligible for surgery or systemic chemotherapy, defined as:\n\nClinical Frailty Scale (CFS) score ≥ 4, or Significant medical comorbidities precluding standard treatment. Patients who decline surgery and chemotherapy after adequate counseling. Age ≥ 19 years. Able to provide written informed consent. Eligible and willing to receive carbon ion radiotherapy.\n\nExclusion Criteria:\n\n* Age \\\u003C 19 years. Presence of distant metastasis at baseline imaging (CT\u002FMRI\u002FPET-CT). Active or uncontrolled infection that may interfere with treatment. Active bleeding or bleeding tendency requiring immediate medical intervention. Pregnant or breastfeeding women. Any condition that, in the investigator's judgment, makes participation unsafe or inappropriate (e.g., severe organ dysfunction preventing radiotherapy).\n\nInability to comply with study procedures or follow-up schedule.","ALL","20 Years",{"count":49,"type":50},33,"ESTIMATED","INTERVENTIONAL",[53],"PHASE2","\"This prospective, single-arm phase II study aims to evaluate the efficacy and safety of carbon ion radiotherapy in frail patients with histologically confirmed, non-metastatic pancreatic cancer who are not eligible for surgery or systemic chemotherapy. Frail status is defined as a Clinical Frailty Scale (CFS) score ≥4 or the presence of significant medical comorbidities limiting aggressive treatment.\n\nCarbon ion radiotherapy, known for its superior dose distribution and high linear energy transfer, may offer improved tumor control with acceptable toxicity in this vulnerable population. This study will assess overall survival, progression-free survival, local control, toxicity, and quality of life.",[56],"Pancreatic Neoplasm","2025-11-30",{"date":59,"type":60},"2025-12-02","ACTUAL",{"date":62,"type":60},"2025-09-23",{"date":64,"type":50},"2029-07",{"name":5,"class":6},1]