Paclitaxel: Patients receive paclitaxel 175mg/㎡ 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.
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.
Bleomycin: Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.
Etoposide: Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.
Cisplatin: Cisplatin 20mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.
Study 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 malignant ovarian germ cell tumor patients after surgery.
Eligibility
Sex
FEMALE
Min age
14 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Progression-free survival — Date of randomization, and death due to any cause, assessed up to 5 years PFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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