[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453048":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":46,"locations":54,"responsibleParty":181,"collaborators":184,"id":201,"slug":202,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":203,"sex":209,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":28,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":28,"overallStatus":57,"whyStopped":28,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},{"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",[55,74,89,103,116,127,140,151,159,172],{"facility":56,"status":57,"city":58,"state":59,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Tongji Hospital, Huazhong University of Science and Technology","RECRUITING","Wuhan","Hubei","China","CN",{"type":63,"coordinates":64},"Point",[65,66],114.26667,30.58333,{"lat":66,"lon":65},[69,72],{"name":70,"role":48,"phone":28,"phoneExt":28,"email":71},"Gang Chen","gumpc@126.com",{"name":73,"role":45,"phone":28,"phoneExt":28,"email":28},"Ding Ma",{"facility":75,"status":57,"city":76,"state":77,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Qilu Hospital of Shandong University","Jinan","Shandong",{"type":63,"coordinates":79},[80,81],116.99722,36.66833,{"lat":81,"lon":80},[84,87],{"name":85,"role":48,"phone":28,"phoneExt":28,"email":86},"Jie Jiang","qljiangjie@aliyun.com",{"name":88,"role":45,"phone":28,"phoneExt":28,"email":28},"Beihua Kong",{"facility":90,"status":57,"city":91,"state":92,"zip":93,"country":60,"countryCode":61,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Women's Hospital School of Medicine Zhejiang University","Hangzhou","Zhejiang","310000",{"type":63,"coordinates":95},[96,97],120.16142,30.29365,{"lat":97,"lon":96},[100,101],{"name":44,"role":48,"phone":49,"phoneExt":28,"email":50},{"name":102,"role":48,"phone":49,"phoneExt":28,"email":53},"Yang Li",{"facility":104,"status":105,"city":106,"state":28,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Peking University Peoples Hospital","NOT_YET_RECRUITING","Beijing",{"type":63,"coordinates":108},[109,110],116.39723,39.9075,{"lat":110,"lon":109},[113,115],{"name":114,"role":48,"phone":28,"phoneExt":28,"email":28},"Zhiqi Wang",{"name":114,"role":45,"phone":28,"phoneExt":28,"email":28},{"facility":117,"status":57,"city":118,"state":28,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Xiangya Hospital of Central South University","Changsha",{"type":63,"coordinates":120},[121,122],112.97087,28.19874,{"lat":122,"lon":121},[125],{"name":126,"role":48,"phone":28,"phoneExt":28,"email":28},"Yu Zhang, MD",{"facility":128,"status":105,"city":129,"state":28,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Sun Yat-Sen University Cancer Hospital","Guangzhou",{"type":63,"coordinates":131},[132,133],113.25,23.11667,{"lat":133,"lon":132},[136,138],{"name":137,"role":48,"phone":28,"phoneExt":28,"email":28},"Yanling Feng",{"name":139,"role":45,"phone":28,"phoneExt":28,"email":28},"Jihong Liu",{"facility":141,"status":57,"city":142,"state":28,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Ningbo First Hospital","Ningbo",{"type":63,"coordinates":144},[145,146],121.54945,29.87819,{"lat":146,"lon":145},[149],{"name":150,"role":48,"phone":28,"phoneExt":28,"email":28},"Yutao Guan",{"facility":152,"status":57,"city":142,"state":28,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":153,"geoPoint":155,"contacts":156},"Ningbo Women and Children's Hospital",{"type":63,"coordinates":154},[145,146],{"lat":146,"lon":145},[157],{"name":158,"role":48,"phone":28,"phoneExt":28,"email":28},"Lingjun Zhao",{"facility":160,"status":105,"city":161,"state":28,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Obstetrics & Gynecology Hospital of Fudan University","Shanghai",{"type":63,"coordinates":163},[164,165],121.45806,31.22222,{"lat":165,"lon":164},[168,171],{"name":169,"role":48,"phone":28,"phoneExt":28,"email":170},"Xiaojun Chen","cxjlhjj@163.com",{"name":169,"role":45,"phone":28,"phoneExt":28,"email":28},{"facility":173,"status":105,"city":161,"state":28,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":174,"geoPoint":176,"contacts":177},"Shanghai First Maternity and Infant Hospital",{"type":63,"coordinates":175},[164,165],{"lat":165,"lon":164},[178,180],{"name":179,"role":48,"phone":28,"phoneExt":28,"email":28},"Xiaoping Wan",{"name":179,"role":45,"phone":28,"phoneExt":28,"email":28},{"type":45,"investigatorFullName":182,"investigatorTitle":183,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Wang Xinyu","Clinical Professor",[185,187,188,189,191,193,194,195,197,199],{"name":186,"class":6},"Tongji Hospital",{"name":75,"class":6},{"name":160,"class":6},{"name":190,"class":6},"Sun Yat-sen University",{"name":192,"class":6},"Peking University People's Hospital",{"name":173,"class":6},{"name":117,"class":6},{"name":196,"class":6},"Anhui Provincial Cancer Hospital",{"name":198,"class":6},"Ningbo Women & Children's Hospital",{"name":200,"class":6},"Ningbo No. 1 Hospital","100453048","profiling-based-endometrial-cancer-adjuvant-therapy-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":213,"type":214},590,"ESTIMATED","INTERVENTIONAL",[217],"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.",[220,221],"Endometrial Cancer Stage I","Endometrial Cancer Stage II","2025-03-26",{"date":224,"type":225},"2025-04-01","ACTUAL",{"date":227,"type":225},"2022-01-24",{"date":229,"type":214},"2027-01-01",{"name":5,"class":6},10]