[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100402080":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":46,"centralContacts":47,"locations":56,"responsibleParty":97,"collaborators":99,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":46,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":46,"enrollmentInfo":115,"targetDuration":46,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":46,"overallStatus":126,"whyStopped":46,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Shanghai Gynecologic Oncology Group","OTHER_GOV",[8,15,21,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 Arm I (low\u002Fmedium tumor burden)","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 gBRCA\u002FsBRCA mutation, CR\u002FPR after platinum-based therapy.",[13,14],"Procedure: Primary debulking surgery","Drug: PARPi",{"label":16,"type":17,"description":18,"interventionNames":19},"Part 1 Arm II (low\u002Fmedium tumor burden)","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 gBRCA\u002FsBRCA mutation, CR\u002FPR after platinum-based therapy.",[20,14],"Procedure: Neoadjuvant chemotherapy",{"label":22,"type":10,"description":11,"interventionNames":23},"Part 2 Arm I (high tumor burden)",[13,14],{"label":25,"type":17,"description":18,"interventionNames":26},"Part 2 Arm II (high tumor burden)",[20,14],[28,35,41],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"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.",[9,22],[34],"PDS",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"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.",[16,25],[40],"Neoadjuvant chemotherapy followed by interval debulking surgery, NACT-IDS",{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","PARPi","For patients with gBRCA\u002FsBRCA mutation and CR\u002FPR after first-line chemotherapy, maintenance therapy of PARP inhibitors.",[9,16,22,25],null,[48,53],{"name":49,"role":50,"phone":51,"phoneExt":46,"email":52},"Lina Shen, MD","CONTACT","86 21 64041990","shen.lina@zs-hospital.sh.cn",{"name":54,"role":50,"phone":51,"phoneExt":46,"email":55},"Tingyu Luan","luan.yuting@zs-hospital.sh.cn",[57,70,79,88],{"facility":58,"status":46,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":46},"Zhongshan Hospital Fudan University","Shanghai","Shanghai Municipality","200032","China","CN",{"type":65,"coordinates":66},"Point",[67,68],121.45806,31.22222,{"lat":68,"lon":67},{"facility":71,"status":46,"city":59,"state":46,"zip":46,"country":62,"countryCode":63,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"Obstetrics & Gynecology Hospital of Fundan University",{"type":65,"coordinates":73},[67,68],{"lat":68,"lon":67},[76],{"name":77,"role":50,"phone":78,"phoneExt":46,"email":46},"Wei Jiang, MD, PhD","86 21 33189900",{"facility":80,"status":46,"city":59,"state":46,"zip":46,"country":62,"countryCode":63,"cosmosGeoPoint":81,"geoPoint":83,"contacts":84},"Shanghai First Maternity and Infant Hospital",{"type":65,"coordinates":82},[67,68],{"lat":68,"lon":67},[85],{"name":86,"role":50,"phone":87,"phoneExt":46,"email":46},"Xiaoqing Guo, MD, PhD","86 21 20261000",{"facility":89,"status":46,"city":59,"state":46,"zip":46,"country":62,"countryCode":63,"cosmosGeoPoint":90,"geoPoint":92,"contacts":93},"Shanghai Jiao Tong University School of Medicine Xinhua Hospital",{"type":65,"coordinates":91},[67,68],{"lat":68,"lon":67},[94],{"name":95,"role":50,"phone":96,"phoneExt":46,"email":46},"Xipeng Wang, MD, PhD","86 21 25078999",{"type":98,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[100,103,105],{"name":101,"class":102},"Obstetrics & Gynecology Hospital of Fudan University","OTHER",{"name":104,"class":102},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"name":80,"class":102},"100402080","phase-3-stratified-evaluation-of-pds-and-nact-ids-in-ovarian-cancer-focus-100402080",false,"NCT04515602","Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer (FOCUS)","Stratified Evaluation and Prediction of Survival Benefit for PDS or NACT-IDS in Advanced Ovarian Cancer, A Randomized, Phase 3 Trial After the SUNNY Study","For Part 1:\n\nInclusion Criteria:\n\n1. Females aged ≥ 18 years.\n2. Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by biopsy or core needle biopsy\\*, laparoscopic biopsy is not recommended). \\* If core needle biopsy could not be performed, patients should satisfy the following conditions:\n\n   1. the patient has a pelvic mass, and\n   2. omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis (FIGO IV), and\n   3. preoperative CA125\u002FCEA ratio \\> 25. If CA125\u002FCEA ratio ≤ 25, imaging or endoscopy is obligatory to exclude a primary gastric, colon, or breast carcinoma.\n3. cPCI score ≤ 8.\n4. Performance status (ECOG 0-2).\n5. Good ASA score (1\u002F2).\n6. 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.\n7. Comply with the study protocol and follow-up.\n8. Patients who have given their written informed consent.\n\nExclusion Criteria:\n\n1. Non-epithelial ovarian malignancies and borderline tumors.\n2. Low grade ovarian cancer.\n3. Mucinous ovarian cancer.\n4. cPCI score \\> 8.\n5. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).\n6. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.\n7. Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.\n\nFor Part 2:\n\nInclusion Criteria:\n\n1. Females aged ≥ 18 years, and \\\u003C 70 years.\n2. Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.\n3. cPCI score ≥ 10.\n4. For FIGO IVB patients, abdominal lesions should be confined to one lobe of liver parenchyma metastasis or splenic metastasis. All extra-abdominal metastases should be resectable, such as inguinal lymph nodes, solitary supraclavicular, retrocrural or paracardial nodes.\n5. Good performance status (ECOG 0-1).\n6. Good ASA score (1\u002F2).\n7. Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery.\n8. Comply with the study protocol and follow-up.\n9. Patients who have given their written informed consent.\n\nExclusion Criteria:\n\n1. Non-epithelial ovarian malignancies and borderline tumors.\n2. Low grade ovarian cancer.\n3. Mucinous ovarian cancer.\n4. Clear cell carcinoma.\n5. cPCI score \\\u003C 8.\n6. Lung metastasis, diffused pleural metastasis, bone metastasis, metastasis of mediastinal lymph node, internal mammary node, or multiple extra-peritoneal lymph nodes.\n7. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).\n8. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.\n9. Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.","FEMALE","18 Years",{"count":116,"type":117},410,"ESTIMATED","INTERVENTIONAL",[120],"PHASE3","The purpose of this study is to answer the fundamental question 'The Optimal Timing of Surgery' in advanced ovarian cancer patients with different tumor burden, and to perform translational study.",[123,124,125],"Epithelial Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Carcinoma","NOT_YET_RECRUITING","2020-08-25",{"date":129,"type":130},"2020-08-27","ACTUAL",{"date":132,"type":117},"2021-01",{"date":134,"type":117},"2028-01",{"name":5,"class":6},4]