TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors (MOGCT-01)
Ovarian Germ Cell Cancer, Ovarian Neoplasms, Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Germ Cell Cancer
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 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.
Sites / Locations
- Qilu Hospital of Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
PT (Arm 1)
BEP (Arm 2)
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.
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. NOTE: *Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses.