Overview

TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal 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 ovarian malignant sex cord-stromal 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.