[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608329":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":28,"locations":28,"responsibleParty":43,"collaborators":28,"id":45,"slug":28,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":28,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":69,"whyStopped":28,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":28},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm (GTV 58.75 Gy\u002F25f)","EXPERIMENTAL","Radiotherapy: long course simultaneous integrated boost radiotherapy\n\n* Gross tumor volume (GTV): A total dose of 58.75Gy delivered in 25 fractions using a simultaneous integrated boost approach.\n* CTV: 45Gy\u002F25f\n* Mesorectum lymph node(GTVnd1):58.75Gy\u002F25f\n* Lateral lymph node（GTVnd2）：60Gy\u002F25f Concurrent Chemotherapy: Concurrent administration of capecitabine (825 mg\u002Fm² twice daily, 5 days per week) or XELOX regimen during radiotherapy After treatment, patients will undergo restaging and proceed to total mesorectal excision (TME) or non-operative management (\"watch-and-wait\") depending on response and clinical assessment.",[13,14,15],"Radiation: GTV 58.75 Gy\u002F25 fractions(Simultaneous Integrated Boost)","Drug: Concurrent Chemotherapy","Procedure: Total mesorectal excision (TME) surgery or non-operative management",{"label":17,"type":18,"description":19,"interventionNames":20},"Control Arm (PGTV 50 Gy\u002F25f)","ACTIVE_COMPARATOR","Radiotherapy: long course simultaneous integrated boost radiotherapy Gross tumor volume (GTV): A total dose of 50Gy delivered in 25 fractions using a simultaneous integrated boost approach.\n\nCTV: 45Gy\u002F25f Mesorectum lymph node(GTVnd1):58.75Gy\u002F25f Lateral lymph node（GTVnd2）：60Gy\u002F25f Concurrent Chemotherapy: Concurrent administration of capecitabine (825 mg\u002Fm² twice daily, 5 days per week) or XELOX regimen during radiotherapy After treatment, patients will undergo restaging and proceed to total mesorectal excision (TME) or non-operative management (\"watch-and-wait\") depending on response and clinical assessment.",[21,14,15],"Radiation: GTV 50 Gy\u002F25 fractions(Simultaneous Integrated Boost)",[23,29,33,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","GTV 58.75 Gy\u002F25 fractions(Simultaneous Integrated Boost)","Patients will receive neoadjuvant long course radiotherapy using VMAT or IMAT with daily image guided.\n\nGross tumor volume (GTV): A total dose of 58.75Gy delivered in 25 fractions using a simultaneous integrated boost approach; CTV: 45Gy\u002F25f; Mesorectum lymph node(GTVnd1):58.75Gy\u002F25f ; Lateral lymph node（GTVnd2）：60Gy\u002F25f;",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"GTV 50 Gy\u002F25 fractions(Simultaneous Integrated Boost)","Patients will receive neoadjuvant radiotherapy with GTV 50 Gy in 25 fractions , delivered with IMRT or VMAT technique.\n\nCTV: 45Gy\u002F25f; Mesorectum lymph node(GTVnd1):58.75Gy\u002F25f; Lateral lymph node（GTVnd2）",[17],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"DRUG","Concurrent Chemotherapy","Concurrent administration of capecitabine (825 mg\u002Fm² twice daily, 5 days per week) or XELOX regimen during radiotherapy.",[17,9],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":28},"PROCEDURE","Total mesorectal excision (TME) surgery or non-operative management","After treatment, patients will undergo restaging and proceed to total mesorectal excision (TME) or non-operative management (\"watch-and-wait\") depending on response and clinical assessment.",[17,9],{"type":44,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100608329",false,"NCT07200141","Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer","Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer：A Phase 2, Randomized Controlled Study","SIB-NCRT-pumch","Inclusion Criteria:\n\n1. Age ≥18 and \\\u003C80 years\n2. Histologically confirmed rectal adenocarcinoma\n3. Tumor located within 10 cm from the anal verge\n4. MRI staging: T3-T4 and\u002For N+, M0 (AJCC 8th edition)\n5. ECOG performance status 0-2\n6. Adequate bone marrow function: WBC ≥3×10⁹\u002FL, ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90 g\u002FL\n7. Adequate liver function: TBIL ≤1.5 × ULN, ALT\u002FAST ≤2.5 × ULN\n8. Adequate renal function: Cr ≤1.5 × ULN or CCr ≥60 mL\u002Fmin\n9. Signed informed consent\n\nExclusion Criteria:\n\n1. Prior rectal cancer surgery\n2. Prior induction chemotherapy, immunotherapy, or pelvic radiotherapy\n3. History of other malignancies\n4. History of chronic colitis, ulcerative colitis, or nonspecific proctitis\n5. Pregnant or breastfeeding women\n6. Active infection or fever\n7. Severe uncontrolled comorbidities (e.g., unstable heart disease, renal disease, chronic hepatitis, uncontrolled diabetes, psychiatric disorders)\n8. Inability to comply with study protocol","ALL","18 Years","80 Years",{"count":56,"type":57},156,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","The goal of this clinical trial is to learn whether new adjuvant radiotherapy with gross tumor volume(GTV) escalated to 58.75 Gy can improve complete response (CR) rates compared with GTV dose of 50 Gy in adult patients (18-79 years) with locally advanced rectal adenocarcinoma (T3-T4\u002FN+, M0) located ≤10 cm from the anal verge.The main questions it aims to answer are:\n\n1. Does GTV simultaneously boost to 58.75 Gy\u002F25f increase complete response (pCR or cCR) compared with 50 Gy\u002F25f?\n2. How do the two regimens differ in terms of progression-free survival (PFS), pelvic local control (LC), tumor regression grade (TRG), organ preservation, and treatment-related toxicity? Researchers will compare GTV 58.75 Gy\u002F25f (experimental arm) versus GTV 50 Gy\u002F25f (control arm) to see if dose escalation improves tumor response rate.\n\nParticipants will:\n\n1. Receive neoadjuvant radiotherapy with one of the two PGTV dose escalated regimens (with concurrent chemotherapy: oral capecitabine or XELOX).\n2. Undergo restaging with imaging and clinical assessment before surgery or observation.\n3. Proceed to total mesorectal excision (TME), local excision, or \"watch-and-wait\" strategy depending on treatment response and patient preference.\n4. Be followed regularly with clinical exams, imaging, endoscopy, and laboratory tests to assess efficacy, safety, and long-term outcomes.",[63],"Locally Advanced Rectal Adenocarcinoma",[65,66,67,68],"locally advanced rectal cancer","Neoadjuvant Chemoradiotherapy","Dose Escalation","Simultaneous Integrated Boost","NOT_YET_RECRUITING","2025-09-22",{"date":72,"type":73},"2025-09-30","ACTUAL",{"date":75,"type":57},"2025-10-01",{"date":77,"type":57},"2028-12-01",{"name":5,"class":6}]