[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453048":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":46,"locations":54,"responsibleParty":180,"collaborators":183,"id":200,"slug":28,"hasResults":201,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":201,"sex":207,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":28,"studyType":213,"phases":214,"briefSummary":216,"conditions":217,"keywords":28,"overallStatus":57,"whyStopped":28,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"fullName":5,"class":6},"Women's Hospital School Of Medicine Zhejiang University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Molecular profile based treatment","EXPERIMENTAL","Determination of the integrated genomic-pathologic profile to determine adjuvant treatment: observation for POLE-mutated profile; vaginal brachytherapy for intermediate profile; chemo-radiotherapy for p53-abnormal profile.",[13,14,15],"Radiation: Vaginal brachytherapy","Other: Observation","Combination Product: Chemoradiation therapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Radiotherapy","ACTIVE_COMPARATOR","Adjuvant vaginal brachytherapy for intermediate risk (stage I A with G3 or stage I B with G1-2) and external beam pelvic radiotherapy for high-intermediate risk (stage I B with G3, or stage II) (standard treatment)",[13,21],"Radiation: External beam radiotherapy",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","Vaginal brachytherapy","Internal radiation of the vaginal vault using a vaginal cylinder. For brachytherapy administered alone it is recommended: suggested dose is either 3 fractions of 7 Gy or 5 fractions of 6 Gy.\n\nFor brachytherapy administered after completion of External beam radiotherapy (EBRT):\n\nTotal dose should aim to be 65 Gy, and suggested dose is 2-3 fractions of 5-6 Gy",[9,17],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"External beam radiotherapy","External beam pelvic radiotherapy on a linear accelerator, 45-50 Gy in 25-28 out-patients sessions",[17],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Observation","No adjuvant therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment",[9],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"COMBINATION_PRODUCT","Chemoradiation therapy","4 adjuvant cycles carboplatin and paclitaxel followed by External beam pelvic radiotherapy (45-50 Gy )",[9],[43],{"name":44,"affiliation":5,"role":45},"Xinyu Wang, MD","PRINCIPAL_INVESTIGATOR",[47,51],{"name":44,"role":48,"phone":49,"phoneExt":28,"email":50},"CONTACT","+86-571-87061501","wangxinyu@zju.edu.cn",{"name":52,"role":48,"phone":49,"phoneExt":28,"email":53},"Yang Li, PhD","li_yang@zju.edu.cn",[55,73,88,102,115,126,139,150,158,171],{"facility":56,"status":57,"city":58,"state":59,"zip":28,"country":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Tongji Hospital, Huazhong University of Science and Technology","RECRUITING","Wuhan","Hubei","China",{"type":62,"coordinates":63},"Point",[64,65],114.26667,30.58333,{"lat":65,"lon":64},[68,71],{"name":69,"role":48,"phone":28,"phoneExt":28,"email":70},"Gang Chen","gumpc@126.com",{"name":72,"role":45,"phone":28,"phoneExt":28,"email":28},"Ding Ma",{"facility":74,"status":57,"city":75,"state":76,"zip":28,"country":60,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Qilu Hospital of Shandong University","Jinan","Shandong",{"type":62,"coordinates":78},[79,80],116.99722,36.66833,{"lat":80,"lon":79},[83,86],{"name":84,"role":48,"phone":28,"phoneExt":28,"email":85},"Jie Jiang","qljiangjie@aliyun.com",{"name":87,"role":45,"phone":28,"phoneExt":28,"email":28},"Beihua Kong",{"facility":89,"status":57,"city":90,"state":91,"zip":92,"country":60,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Women's Hospital School of Medicine Zhejiang University","Hangzhou","Zhejiang","310000",{"type":62,"coordinates":94},[95,96],120.16142,30.29365,{"lat":96,"lon":95},[99,100],{"name":44,"role":48,"phone":49,"phoneExt":28,"email":50},{"name":101,"role":48,"phone":49,"phoneExt":28,"email":53},"Yang Li",{"facility":103,"status":104,"city":105,"state":28,"zip":28,"country":60,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Peking University Peoples Hospital","NOT_YET_RECRUITING","Beijing",{"type":62,"coordinates":107},[108,109],116.39723,39.9075,{"lat":109,"lon":108},[112,114],{"name":113,"role":48,"phone":28,"phoneExt":28,"email":28},"Zhiqi Wang",{"name":113,"role":45,"phone":28,"phoneExt":28,"email":28},{"facility":116,"status":57,"city":117,"state":28,"zip":28,"country":60,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Xiangya Hospital of Central South University","Changsha",{"type":62,"coordinates":119},[120,121],112.97087,28.19874,{"lat":121,"lon":120},[124],{"name":125,"role":48,"phone":28,"phoneExt":28,"email":28},"Yu Zhang, MD",{"facility":127,"status":104,"city":128,"state":28,"zip":28,"country":60,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Sun Yat-Sen University Cancer Hospital","Guangzhou",{"type":62,"coordinates":130},[131,132],113.25,23.11667,{"lat":132,"lon":131},[135,137],{"name":136,"role":48,"phone":28,"phoneExt":28,"email":28},"Yanling Feng",{"name":138,"role":45,"phone":28,"phoneExt":28,"email":28},"Jihong Liu",{"facility":140,"status":57,"city":141,"state":28,"zip":28,"country":60,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Ningbo First Hospital","Ningbo",{"type":62,"coordinates":143},[144,145],121.54945,29.87819,{"lat":145,"lon":144},[148],{"name":149,"role":48,"phone":28,"phoneExt":28,"email":28},"Yutao Guan",{"facility":151,"status":57,"city":141,"state":28,"zip":28,"country":60,"cosmosGeoPoint":152,"geoPoint":154,"contacts":155},"Ningbo Women and Children's Hospital",{"type":62,"coordinates":153},[144,145],{"lat":145,"lon":144},[156],{"name":157,"role":48,"phone":28,"phoneExt":28,"email":28},"Lingjun Zhao",{"facility":159,"status":104,"city":160,"state":28,"zip":28,"country":60,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Obstetrics & Gynecology Hospital of Fudan University","Shanghai",{"type":62,"coordinates":162},[163,164],121.45806,31.22222,{"lat":164,"lon":163},[167,170],{"name":168,"role":48,"phone":28,"phoneExt":28,"email":169},"Xiaojun Chen","cxjlhjj@163.com",{"name":168,"role":45,"phone":28,"phoneExt":28,"email":28},{"facility":172,"status":104,"city":160,"state":28,"zip":28,"country":60,"cosmosGeoPoint":173,"geoPoint":175,"contacts":176},"Shanghai First Maternity and Infant Hospital",{"type":62,"coordinates":174},[163,164],{"lat":164,"lon":163},[177,179],{"name":178,"role":48,"phone":28,"phoneExt":28,"email":28},"Xiaoping Wan",{"name":178,"role":45,"phone":28,"phoneExt":28,"email":28},{"type":45,"investigatorFullName":181,"investigatorTitle":182,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Wang Xinyu","Clinical Professor",[184,186,187,188,190,192,193,194,196,198],{"name":185,"class":6},"Tongji Hospital",{"name":74,"class":6},{"name":159,"class":6},{"name":189,"class":6},"Sun Yat-sen University",{"name":191,"class":6},"Peking University People's Hospital",{"name":172,"class":6},{"name":116,"class":6},{"name":195,"class":6},"Anhui Provincial Cancer Hospital",{"name":197,"class":6},"Ningbo Women & Children's Hospital",{"name":199,"class":6},"Ningbo No. 1 Hospital","100453048",false,"NCT05179447","PROfiling Based Endometrial Cancer Adjuvant Therapy","Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma","PROBEAT","Inclusion Criteria:\n\n1. Surgery consisting of a total abdominal or laparoscopic hysterectomy, bilateral salpingectomy, pelvic lymphadenectomy or sentinel lymph node mapping and dissection, with or without para-aortic lymphadenectomy, oophorectomy\n2. Histologically confirmed endometrioid type endometrial carcinoma, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I, with one of the following combinations of stage and grade:\n\n   Stage I A, grade 3 Stage I B, grade 1 or 2 Stage I B, grade 3 Stage II\n3. World Health Organization (WHO)-performance status 0-2\n4. Written informed consent\n\nExclusion Criteria:\n\n1. With residual disease\n2. Any other stage and type of endometrial carcinoma\n3. Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma\n4. Uterine sarcoma (including carcinosarcoma)\n5. Previous malignancy (except for non-melanomatous skin cancer)\n6. Previous pelvic radiotherapy\n7. Expected interval between the operation and start of radiotherapy exceeding 8 weeks","FEMALE","18 Years","75 Years",{"count":211,"type":212},590,"ESTIMATED","INTERVENTIONAL",[215],"NA","This is a prospective, multicenter, randomized phase III trial among women with endometrioid adenocarcinoma with high-intermediate and intermediate risk features to investigate the role of integrated genomic-pathologic classification to determine if participants should receive no adjuvant therapy, vaginal brachytherapy, external beam radiotherapy or chemo-radiation therapy based on molecular features as compared to standard radiation therapy.",[218,219],"Endometrial Cancer Stage I","Endometrial Cancer Stage II","2025-03-26",{"date":222,"type":223},"2025-04-01","ACTUAL",{"date":225,"type":223},"2022-01-24",{"date":227,"type":212},"2027-01-01",{"name":5,"class":6},10]