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Recruiting Phase 3 NCT02429700

TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors

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Trial Parameters

Condition Ovarian Sex Cord Stromal Tumor
Sponsor Beihua Kong
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 132
Sex FEMALE
Min Age 14 Years
Max Age 65 Years
Start Date 2015-04
Completion 2025-05
Interventions
PaclitaxelCarboplatinBleomycin

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Age≤65 years; female, Chinese women; * Histologically confirmed ovarian stromal tumor, including the following cell types: * Granulosa cell tumor * Granulosa cell-theca cell tumor * Sertoli-Leydig cell tumor (androblastoma) * Steroid (lipid) cell tumor * Gynandroblastoma * Unclassified sex cord-stromal tumor * Sex cord tumor with annular tubules * Newly diagnosed, stage IIA-IVB disease; * Has undergone initial surgery (for diagnosis, staging, or cytoreduction) within the past 8 weeks. * May or may not have measurable residual disease. * Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal * Performance status: Karnofsky score≥60; * Provide written informed consent. Exclusion Criteria: * With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for chemotherapy; * History of organ transplantation, immune

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