[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454647":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":48,"centralContacts":53,"locations":62,"responsibleParty":164,"collaborators":166,"id":169,"slug":170,"hasResults":171,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":47,"eligibilityCriteria":175,"healthyVolunteers":171,"sex":176,"minAge":177,"maxAge":47,"enrollmentInfo":178,"targetDuration":47,"studyType":181,"phases":182,"briefSummary":184,"conditions":185,"keywords":189,"overallStatus":65,"whyStopped":47,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"Shanghai Gynecologic Oncology Group","OTHER_GOV",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Upfront cytoreductive surgery with maintenance therapy","EXPERIMENTAL","Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR\u002FPR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).",[13,14,15],"Procedure: Primary debulking surgery","Drug: PARP inhibitor","Drug: Bevacizumab",{"label":17,"type":18,"description":19,"interventionNames":20},"Neoadjuvant chemotherapy with maintenance therapy","ACTIVE_COMPARATOR","Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR\u002FPR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).",[21,14,15],"Procedure: Neoadjuvant chemotherapy",[23,30,36,43],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Primary debulking surgery","Primary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg\u002Fm2 or Docetaxel 60-75 mg\u002Fm2 plus Carboplatin AUC (area under the curve) 5.",[9],[29],"PDS",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Neoadjuvant chemotherapy","3 cycles of Paclitaxel 175mg\u002Fm2 or Docetaxel 60-75 mg\u002Fm2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy.",[17],[35],"Neoadjuvant chemotherapy followed by interval debulking surgery, NACT-IDS",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","PARP inhibitor","For patients with BRCA mutated, maintenance therapy of PARP inhibitors following CR\u002FPR after first-line chemotherapy. In this trial, Olaparib 300mg p.o. twice daily is suggested after the front-line therapy.",[17,9],[42],"Olaparib",{"type":37,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Bevacizumab","For patients without BRCA mutated, maintenance therapy of Bevacizumab following CR\u002FPR after first-line chemotherapy. In this trial, Bevacizumab 7.5mg per kilogram intravenous once every 3 weeks is suggested after the front-line therapy.",[17,9],null,[49],{"name":50,"affiliation":51,"role":52},"Libing Xiang","Fudan University","STUDY_CHAIR",[54,59],{"name":50,"role":55,"phone":56,"phoneExt":57,"email":58},"CONTACT","86 21 64041990","2801","xiang.libing@zs-hospital.sh.cn",{"name":60,"role":55,"phone":56,"phoneExt":57,"email":61},"Rong Jiang","jiang.rong@zs-hospital.sh.cn",[63,79,91,103,112,124,136,145,154],{"facility":64,"status":65,"city":66,"state":47,"zip":47,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"The First People's Hospital of Foshan","RECRUITING","Foshan","China","CN",{"type":70,"coordinates":71},"Point",[72,73],113.13148,23.02677,{"lat":73,"lon":72},[76],{"name":77,"role":55,"phone":47,"phoneExt":47,"email":78},"Songhua Yuan","yuan-sh09@163.com",{"facility":80,"status":65,"city":81,"state":47,"zip":47,"country":67,"countryCode":68,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Sun Yet-Sen University Cancer Center","Guangzhou",{"type":70,"coordinates":83},[84,85],113.25,23.11667,{"lat":85,"lon":84},[88],{"name":89,"role":55,"phone":47,"phoneExt":47,"email":90},"Chuyao Zhang","zhangchy@sysucc.org.cn",{"facility":92,"status":65,"city":93,"state":47,"zip":47,"country":67,"countryCode":68,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou",{"type":70,"coordinates":95},[96,97],120.16142,30.29365,{"lat":97,"lon":96},[100],{"name":101,"role":55,"phone":47,"phoneExt":47,"email":102},"Jianhua Qian","qianjianhua@zju.edu.cn",{"facility":104,"status":65,"city":93,"state":47,"zip":47,"country":67,"countryCode":68,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Zhejiang Cancer Hospital",{"type":70,"coordinates":106},[96,97],{"lat":97,"lon":96},[109],{"name":110,"role":55,"phone":47,"phoneExt":47,"email":111},"Yingli Zhang","zhangyl@zjcc.org.cn",{"facility":113,"status":65,"city":114,"state":47,"zip":47,"country":67,"countryCode":68,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"The First Affiliated Hospital of University of Science and Technology of China","Hefei",{"type":70,"coordinates":116},[117,118],117.28083,31.86389,{"lat":118,"lon":117},[121],{"name":122,"role":55,"phone":47,"phoneExt":47,"email":123},"Ying Zhou","caddiezy@ustc.edu.cn",{"facility":125,"status":65,"city":126,"state":47,"zip":47,"country":67,"countryCode":68,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Fudan University Cancer Hospital","Shanghai",{"type":70,"coordinates":128},[129,130],121.45806,31.22222,{"lat":130,"lon":129},[133],{"name":134,"role":55,"phone":47,"phoneExt":47,"email":135},"Huijuan Yang","huijuanyang@hotmail.com",{"facility":137,"status":65,"city":126,"state":47,"zip":47,"country":67,"countryCode":68,"cosmosGeoPoint":138,"geoPoint":140,"contacts":141},"Obstetrics and Gynecology Hospital of Fundan University",{"type":70,"coordinates":139},[129,130],{"lat":130,"lon":129},[142],{"name":143,"role":55,"phone":47,"phoneExt":47,"email":144},"Wei Jiang","jiangwei1436@fckyy.org.cn",{"facility":146,"status":65,"city":126,"state":47,"zip":47,"country":67,"countryCode":68,"cosmosGeoPoint":147,"geoPoint":149,"contacts":150},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"type":70,"coordinates":148},[129,130],{"lat":130,"lon":129},[151],{"name":152,"role":55,"phone":47,"phoneExt":47,"email":153},"Xipeng Wang","xipengwang@hotmail.com",{"facility":155,"status":65,"city":126,"state":47,"zip":47,"country":67,"countryCode":68,"cosmosGeoPoint":156,"geoPoint":158,"contacts":159},"Zhongshan Hospital, Fudan University",{"type":70,"coordinates":157},[129,130],{"lat":130,"lon":129},[160,162],{"name":50,"role":55,"phone":161,"phoneExt":57,"email":58},"862164041990",{"name":50,"role":163,"phone":47,"phoneExt":47,"email":47},"PRINCIPAL_INVESTIGATOR",{"type":165,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[167],{"name":51,"class":168},"OTHER","100454647","phase-2-surgery-combined-with-maintenance-targeted-therapy-in-the-treatment-of-advanced-ovarian-cancer-100454647",false,"NCT05200260","Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer","A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer","Inclusion Criteria:\n\n* Females aged ≥ 18 years.\n* Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma\n* Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET\u002FCT examination\n* Complete cytoreduction can be achieved based on CT or PET\u002FCT examination\n* Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing\n* Performance status (ECOG 0-2)\n* Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:\n\n  1. white blood cells \\>3,000\u002FµL, absolute neutrophil count ≥1,500\u002FµL, platelets ≥100,000\u002FµL, hemoglobin ≥9 g\u002FdL,\n  2. serum creatinine \\\u003C1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL\u002Fmin according to Cockroft-Gault formula or to local lab measurement,\n  3. serum bilirubin \\\u003C1.25 x UNL, AST(SGOT) and ALT(SGPT) \\\u003C2.5 x UNL.\n* Comply with the study protocol and follow-up.\n* Patients who have given their written informed consent.\n\nExclusion Criteria:\n\n* Non-epithelial ovarian malignancies and borderline tumors\n* Low grade ovarian cancer\n* Mucinous ovarian cancer\n* Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases\n* Patient has a known hypersensitivity to the components of olaparib\u002Fbevacizumab or its excipients\n* Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage).\n* Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise adherence to the protocol.\n* Other conditions, such as religious, psychological, and other factors, that could interfere with the provision of informed consent, compliance to study procedures, or follow-up.","FEMALE","18 Years",{"count":179,"type":180},220,"ESTIMATED","INTERVENTIONAL",[183],"PHASE2","Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer",[186,187,188],"Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Carcinoma",[186,190,31,191,44],"Primary Debulking Surgery","Poly-adenosine Ribose Phosphate Inhbitors (PARPi)","2025-02-06",{"date":194,"type":195},"2025-02-10","ACTUAL",{"date":197,"type":195},"2022-07-13",{"date":199,"type":180},"2027-06",{"name":5,"class":6},9]