[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100242087":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":56,"centralContacts":61,"locations":66,"responsibleParty":81,"collaborators":85,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":36,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":36,"overallStatus":68,"whyStopped":36,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Shandong University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"PT (Arm 1)","EXPERIMENTAL","Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.",[13,14],"Drug: Paclitaxel","Drug: Carboplatin",{"label":16,"type":17,"description":18,"interventionNames":19},"BEP (Arm 2)","ACTIVE_COMPARATOR","Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4\\* courses in the absence of disease progression or unacceptable toxicity.\n\nNOTE: \\*Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses.",[20,21,22],"Drug: Bleomycin","Drug: Etoposide","Drug: Cisplatin",[24,32,37,45,52],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Paclitaxel","Patients receive paclitaxel 175mg\u002F㎡ IV over 3 hours on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.",[9],[30,31],"Anzatax","TAX",{"type":25,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Carboplatin","and carboplatin AUC 5-6 IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.",[9],null,{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Bleomycin","Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.",[16],[42,43,44],"Blanoxan","BLEO","BLM",{"type":25,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Etoposide","Etoposide 100mg\u002F㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.",[16],[50,51],"ETOP","Etopophos",{"type":25,"name":53,"description":54,"armGroupLabels":55,"otherNames":36},"Cisplatin","Cisplatin 20mg\u002F㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.",[16],[57],{"name":58,"affiliation":59,"role":60},"Beihua Kong, MD. PhD.","Qilu Hospital of Shandong University","PRINCIPAL_INVESTIGATOR",[62],{"name":58,"role":63,"phone":64,"phoneExt":36,"email":65},"CONTACT","+8618560081888","kongbeihua@sdu.edu.cn",[67],{"facility":59,"status":68,"city":69,"state":70,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"RECRUITING","Jinan","Shandong","China","CN",{"type":74,"coordinates":75},"Point",[76,77],116.99722,36.66833,{"lat":77,"lon":76},[80],{"name":58,"role":63,"phone":36,"phoneExt":36,"email":36},{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"SPONSOR_INVESTIGATOR","Beihua Kong","MD. PhD.",[86,88,90],{"name":87,"class":6},"Huazhong University of Science and Technology",{"name":89,"class":6},"Zhejiang University",{"name":91,"class":6},"Sun Yat-sen University","100242087","phase-3-tc-or-bep-in-treating-patients-with-ovarian-malignant-sex-cord-stromal-tumors-100242087",false,"NCT02429700","TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors","A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Ovarian Malignant Sex Cord-Stromal Tumors","SCST-01","Inclusion Criteria:\n\n* Age≤65 years; female, Chinese women;\n* Histologically confirmed ovarian stromal tumor, including the following cell types:\n\n  * Granulosa cell tumor\n  * Granulosa cell-theca cell tumor\n  * Sertoli-Leydig cell tumor (androblastoma)\n  * Steroid (lipid) cell tumor\n  * Gynandroblastoma\n  * Unclassified sex cord-stromal tumor\n  * Sex cord tumor with annular tubules\n* Newly diagnosed, stage IIA-IVB disease;\n\n  * Has undergone initial surgery (for diagnosis, staging, or cytoreduction) within the past 8 weeks.\n  * May or may not have measurable residual disease.\n* Laboratory tests: WBC≥4×10(9)\u002FL, NEU≥2×10(9)\u002FL, PLT≥80×10(9)\u002FL, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal\n* Performance status: Karnofsky score≥60;\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* With severe or uncontrolled internal disease, unable to receive surgery and\u002For unsuitable for chemotherapy;\n* History of organ transplantation, immune diseases;\n* History of serious mental illness, a history of brain dysfunction;\n* Drug abuse or a history of drug abuse;\n* Suffering from other malignancies;\n* Concurrently participating in other clinical trials\n* Unable or unwilling to sign informed consents;\n* Unable or unwilling to abide by protocol.","FEMALE","14 Years","65 Years",{"count":104,"type":105},132,"ESTIMATED","INTERVENTIONAL",[108],"PHASE3","Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has the same curative effects and less adverse effects than bleomycin, etoposide and cisplatin(BEP) among newly diagnosed ovarian malignant sex cord-stromal tumor patients after surgery.",[111,112,113],"Ovarian Sex Cord Stromal Tumor","Ovarian Neoplasms","Ovarian Cancer","2023-04-22",{"date":116,"type":117},"2023-04-25","ACTUAL",{"date":119,"type":36},"2015-04",{"date":121,"type":105},"2030-05",{"name":83,"class":6},1]