TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors

• Status: Recruiting
• Trial end date: 2030-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beihua Kong
• Collaborators: Huazhong University of Science and Technology; Sun Yat-sen University; Zhejiang University
• Treatments: Albumin-Bound Paclitaxel; Bleomycin; Carboplatin; Cisplatin; Etoposide; Etoposide phosphate; Paclitaxel

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.