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

Recruiting now · Phase 3

Conditions studied: Ovarian Germ Cell Cancer, Ovarian Neoplasms, Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT02429687

Run by

Beihua Kong

People needed

129

Starts

2015-04-01

Expected to finish

2030-05-01

Last updated by the study team

2023-04-25

Who can join

Age: 14 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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