[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479546":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":40,"centralContacts":46,"locations":40,"responsibleParty":54,"collaborators":56,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":40,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":40,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":99,"whyStopped":40,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":40},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Molecular classification based treatment","EXPERIMENTAL","Establishment of molecular-clinicopathological classification to make adjuvant treatment decisions: observation for favourable group; vaginal brachytherapy(VBT) for intermediate group; external beam radiotherapy(EBRT) for unfavourable group.\n\nMolecular-clinicopathological classification strategy：Favourable group：POLE-mutated. CTNNB1(wide-type)with IA (G1-3) or IB(G1-2)and LVSI(lymph-vascular space invasion) focal\u002F-.\n\nIntermediate group：MMRD and LVSI focal\u002F-. CTNNB1(wide-type) and IB(G3) or II with LVSI focal\u002F-. CTNNB1-mutated and IA(G1-3) or IB (G1-2) with LVSI focal\u002F-.\n\nUnfavourable group: TP53 mutation. CTNNB1-mutated and IB (G3) or II. Substantial LVSI.",[13,14,15,16],"Radiation: Vaginal brachytherapy","Radiation: Pelvic external beam radiotherapy","Other: Observation","Drug: Chemotherapy",{"label":18,"type":19,"description":20,"interventionNames":21},"Conventional risk stratification based treatment","ACTIVE_COMPARATOR","Adjuvant vaginal brachytherapy alone for intermediate risk patients (IA G1-2 with LVSI present or age\\>60, IA G3 or IB G1-2 regardless of LVSI status).\n\nEBRT for high-intermediate risk (stage I B with G3, or stage II)",[13,14,16],[23,30,36,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","Vaginal brachytherapy","High-dose rate vaginal brachytherapy (VBT) was delivered with a vaginal cylinder.For VBT administered alone, the dose is recommended: 3 fractions of 7 Gy or 5 fractions of 6 Gy or 6 fractions of 5 Gy.\n\nFor VBT administered after completion of EBRT: 2-3 fractions of 4-6 Gy.",[18,9],[29],"VBT",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Pelvic external beam radiotherapy","EBRT was delivered to the pelvic area using a total dose of 45-50.4Gy in 25-28 fractions over 5-6 weeks with the intensity-modulated radiotherapy (IMRT) technique, three-dimensional conformal radiotherapy (3D-CRT) modality",[18,9],[35],"Pelvic EBRT",{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Observation","No radiotherapy is administrated, but active follow-up and quality of life questionnaires is needed after surgery.",[9],null,{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":40},"DRUG","Chemotherapy","Intravenous concurrent or sequential adjuvant chemotherapy consists of carboplatin\u002Fpaclitaxel, cisplatin\u002Fdoxorubicin or cisplatin\u002Fdoxorubicin\u002Fpaclitaxel, etc.",[18,9],[47,52],{"name":48,"role":49,"phone":50,"phoneExt":40,"email":51},"Xiaorong Hou, PhD","CONTACT","+86-13811963013","hxr_pumch@163.com",{"name":48,"role":49,"phone":53,"phoneExt":40,"email":51},"+86-01069155487",{"type":55,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[57,59,61,63,65,67,69,71,73,75],{"name":58,"class":6},"The First Affiliated Hospital of Air Force Medicial University",{"name":60,"class":6},"The Second Affiliated Hospital of Dalian Medical University",{"name":62,"class":6},"Second Hospital of Jilin University",{"name":64,"class":6},"First Affiliated Hospital Xi'an Jiaotong University",{"name":66,"class":6},"The Affiliated Hospital of Inner Mongolia Medical University",{"name":68,"class":6},"Third Affiliated Hospital of Xinjiang Medical University",{"name":70,"class":6},"Peking University First Hospital",{"name":72,"class":6},"940 Hospital of the People's Liberation Army Joint Logistic Support Force",{"name":74,"class":6},"Xiangya Hospital of Central South University",{"name":76,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","100479546","phase-3-study-of-early-stage-endometrial-cancer-based-on-molecular-classification-and-traditional-risk-stratification-to-guide-adjuvant-radiotherapy-decisions-100479546",false,"NCT05524389","Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions","A Prospective Multicentre Phase III Randomised Open Clinical Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions","Inclusion Criteria:\n\n1. Women aged 18-75.\n2. Patients with newly histologically confirmed Endometrioid adenocarcinoma.\n3. ECOG score 0-2\n4. Surgery consisting of a total hysterectomy and bilateral salpingo-oophorectomy, pelvic lymphadenectomy or sentinel lymph node biopsy, with or without para-aortic lymphadenectomy, oophorectomy\n5. Patients with FIGO staging(2009 edition) I or II and meet one of the following conditions:\n\n   1. Stage IA G1-2 with massive LVSI+ or age ≥ 60 years\n   2. Stage IA G3, regardless of LVSI status\n   3. Stage IB G1-3, regardless of LVSI status\n   4. Stage II, regardless of tumor grade and LVSI status\n6. Patients can understand the study protocol and voluntarily participate in the study, and give written informed consent before treatment.\n\nExclusion Criteria:\n\n1. Not FIGO stage I-II.\n2. Residual tumor or positive margin.\n3. Mixed carcinoma, sarcoma or carcinosarcoma\n4. Previous history of malignant tumor\n5. Previous history of pelvic radiotherapy\n6. The interval between surgery and radiotherapy is more than 12 weeks.\n7. With serious medical complications, such as heart disease, lung disease and other diseases that cannot tolerate the whole course of radiotherapy","FEMALE","18 Years","75 Years",{"count":88,"type":89},624,"ESTIMATED","INTERVENTIONAL",[92],"PHASE3","The purpose of this study is to compare the efficacy and toxicity of early stage endometrial cancer based on molecular classification and conventional risk stratification adjuvant therapy decision-making, and to provide high-quality evidence-based medical evidence for individualized adjuvant therapy selection under the guidance of fine stratification system of endometrial cancer.",[95,96,97],"Endometrial Cancer","Adjuvant Radiotherapy","Molecular Classification",[95],"NOT_YET_RECRUITING","2022-11-20",{"date":102,"type":103},"2022-11-23","ACTUAL",{"date":105,"type":89},"2022-12-01",{"date":107,"type":89},"2027-06-30",{"name":5,"class":6}]