[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565396":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":56,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Radiotherapy +Concurrent Chemotherapy or Immunotherapy Experimental",[13],"Combination Product: Moderated hypofractionated online adaptive radiotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Radiotherapy +Concurrent Chemotherapy or Immunotherapy Standard of Care",[19],"Combination Product: Conventional radiotherapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Moderated hypofractionated online adaptive radiotherapy","Radiation: Moderated hypofractionated online adaptive radiotherapy (oART)+ High-dose rate (HDR) Brachytherapy\n\nExperimental group: 43.35Gy\u002F17F external beam radiotherapy with oART + HDR-Brachytherapy\n\nDrug: Concurrent Chemotherapy or immunotherapy\n\nWeekly cisplatin 40 mg\u002Fm2 or PD-1 inhibitors",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional radiotherapy","Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy\n\nContral group: 45Gy\u002F25F EBRT + HDR-Brachytherapy\n\nDrug: Concurrent Chemotherapy or immunotherapy\n\nWeekly cisplatin 40 mg\u002Fm2 or PD-1 inhibitors",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Zheng Zeng, MD.","CONTACT","86-10-6512-4875","zengzheng1206@163.com",[38],{"facility":5,"status":39,"city":40,"state":26,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Beijing","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":51,"role":34,"phone":52,"phoneExt":26,"email":53},"Junfang Yan, MD","01069155484","yanjunfang@pumch.cn",{"type":55,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[57,59,61],{"name":58,"class":6},"Peking University Cancer Hospital & Institute",{"name":60,"class":6},"Shandong Cancer Hospital and Institute",{"name":62,"class":6},"Ruijin Hospital","100565396","phase-3-moderated-hypofractionated-online-adaptive-radiotherapy-in-cervical-cancer-100565396",false,"NCT06641635","Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer","A Multicenter, Non-inferiority, Phase 3, Randomized Controlled Study of Moderated Hypofractionated Online Adaptive Radiotherapy for Cervical Cancer","Inclusion Criteria:\n\n1. The patient is fully voluntary and has the capacity for autonomy, signing the informed consent form 30 days prior to enrollment\n2. Age ≥18 and ≤75 years\n3. FIGO stage IB-IIIB cervical cancer; IIIC1 (lymph node metastasis ≤2 cm, without common iliac lymph node metastasis)\n4. Pathologically diagnosed as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma\n5. Concurrent weekly cisplatin therapy ± immunotherapy\n6. Able to undergo brachytherapy\n7. ECOG performance status of 0-1, with an expected ability to tolerate lying flat for half an hour.\n\nExclusion Criteria:\n\n1. Patients who have undergone cervical cancer surgery, excluding pelvic lymphadenectomy or pelvic lymph node dissection, or cervical conization\n2. FIGO stages IA, IIIC2, IVA, or IVB\n3. FIGO stage IIIC1 with lymph nodes \\>2 cm, or with common iliac lymph node metastasis\n4. History of prior abdominal or pelvic radiotherapy\n5. Pregnant or breastfeeding women\n6. Patients with active infections or fever\n7. Other severe diseases that may significantly affect clinical trial compliance, such as unstable heart disease, kidney disease, chronic hepatitis requiring treatment, poorly controlled diabetes, or mental disorders.","FEMALE","18 Years","75 Years",{"count":74,"type":75},440,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","The most common external beam radiotherapy fractionation scheme for cervical cancer is 45-50.4 Gy delivered in 25-28 fractions. However, prolonged treatment duration can lead to insufficient availability of medical resources. We hope to assess the safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with brachytherapy in patients with cervical cancer in a multicenter study.",[81,82],"Cervical Cancer","Adaptive Radiotherapy",[81,84,82,85],"Moderated Hypofractionated Radiotherapy","Randomized controlled trial","2025-03-13",{"date":88,"type":89},"2025-03-18","ACTUAL",{"date":91,"type":89},"2024-11-19",{"date":93,"type":75},"2029-10-31",{"name":5,"class":6},1]