TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors
Recruiting
Phase 3Interventional Study
Ovarian Sex Cord Stromal TumorOvarian NeoplasmsOvarian Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
14 – 65
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
132 (estimated)
Sponsor
Beihua Kong · Other
Who this trial is looking for
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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.
Trial Locations
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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
* Gynandrobla…
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.
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