Actively Recruiting
TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors
Led by Beihua Kong · Updated on 2023-04-25
129
Participants Needed
1
Research Sites
787 weeks
Total Duration
On this page
Sponsors
B
Beihua Kong
Lead Sponsor
H
Huazhong University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female Chinese women aged 14 to 65 years
- Histologically confirmed ovarian stromal tumor including granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor, steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, or sex cord tumor with annular tubules
- Newly diagnosed stage IIA-IVB disease
- Underwent initial surgery for diagnosis, staging, or cytoreduction within the past 8 weeks
- May have measurable residual disease
- Laboratory tests showing WBC ≥ 4 x 10(9)/L, NEU ≥ 2 x 10(9)/L, PLT ≥ 80 x 10(9)/L, serum bilirubin ≤ 1.5 times upper limit of normal, transaminase ≤ 1.5 times upper limit of normal, normal BUN and creatinine
- Karnofsky performance status score ≥ 60
- Provided written informed consent
You will not qualify if you...
- Severe or uncontrolled internal disease preventing surgery or chemotherapy
- History of organ transplantation or immune diseases
- History of serious mental illness or brain dysfunction
- Current or past drug abuse
- Having other malignancies
- Currently participating in other clinical trials
- Unable or unwilling to sign informed consent
- Unable or unwilling to follow the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
B
Beihua Kong, MD. PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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