TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors (NCT02429700) | Clinical Trial Compass
RecruitingPhase 3
TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors
China132 participantsStarted 2015-04
Plain-language 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.
Who can participate
Age range14 Years – 65 Years
SexFEMALE
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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 diseases;
* History of serious mental illness, a history of brain dysfunction;
* Drug abuse or a history of drug abuse;
* Suffering from other malignancies;
* Concurrently participating in other clinical trials
* Unable or unwilling to sign informed consents;
* Unable or unwilling to abide by protocol.
What they're measuring
1
Progression-free survival
Timeframe: Date of randomization, and death due to any cause, assessed up to 5 years