[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bulky-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bulky-tumor":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"100655895","proton-and-proton-photon-hybrid-partial-stereotactic-ablative-boost-radiotherapy-p-sabr-for-unresectable-large-tumors-100655895",false,"NCT07818798","Proton and Proton-Photon Hybrid Partial Stereotactic Ablative Boost Radiotherapy (P-SABR) for Unresectable Large Tumors","A Prospective, Multicenter, Observational Cohort Study of Proton and Proton-Photon Hybrid Partial Stereotactic Ablative Boost Radiotherapy (P-SABR) for Unresectable Large Tumors","LARGE-Proton","Inclusion Criteria:\n\n* Histologically or cytologically confirmed malignancy\n* At least one tumor with a longest diameter \\> 5 cm\n* Not amenable to curative surgical resection, or patient declines surgery, or surgery contraindicated because of medical comorbidities\n* Age ≥ 18 years\n* ECOG performance status 0-2\n* Life expectancy \\> 3 months\n* Written informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy to the same site\n* Severe cardiopulmonary insufficiency precluding radiotherapy\n* Concurrent other active malignancy\n* Uncontrolled acute infection or bowel obstruction\n* Pregnancy or breastfeeding\n* Intracranial lesion\n* Tumor directly invading the full thickness of the esophageal, gastric or intestinal wall with active ulceration, fistula or uncontrolled risk of perforation (tumors that only abut or displace a hollow organ without full-thickness invasion are not excluded)\n* Uncontrolled active tumor bleeding, or impending pathological fracture requiring orthopedic intervention\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for the study","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","OBSERVATIONAL","This prospective, multicenter, observational cohort study will enroll 60 adults with unresectable larege tumors (longest diameter \\> 5 cm) who receive one of two treatment modes: (A) proton P-SABR, in which both the proton partial-SABR boost (course 1) and the subsequent proton CFRT (course 2) are delivered at the proton center; or (B) proton-photon hybrid P-SABR, in which course 1 is delivered with protons at the proton center and course 2 CFRT is delivered with photons. The primary objective is to describe, in each cohort, the incidence of treatment-related grade ≥ 3 acute and late adverse events (CTCAE v5.0). Secondary objectives are dosimetric and the 1-year local control rate (RECIST 1.1, in-field). Participants are followed for up to 5 years.",[25,26,27],"Unresectable Malignant Neoplasm","Bulky Tumor","Solid Tumor",[29,30,31,32,33,34,35,36,37,38],"partial stereotactic ablative boost radiotherapy","P-SABR","proton therapy","proton-photon hybrid radiotherapy","bulky tumor","large tumor","stereotactic ablative radiotherapy","spatially fractionated radiotherapy","biologically effective dose","conventionally fractionated radiotherapy","NOT_YET_RECRUITING","2026-09-09",{"date":42,"type":43},"2026-09-14","ACTUAL",{"date":45,"type":21},"2026-10",{"date":47,"type":21},"2029-12",{"name":49,"class":50},"Peking University First Hospital","OTHER"]