This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin
as the first-line regimen in the treatment of high risk gestational trophoblastic tumor.
Drug: actinomycin D
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Full eligibility criteria for NCT02639650
Ages eligible for Study
up to 60 Years
Genders eligible for Study
Accepts Healthy Volunteers
Patients who International Federation of Gynecology and Obstetrics (FIGO) Stage I, II, or III criteria for high-risk gestational trophoblastic neoplasia (GTN) and stage Ⅳ cases
World Health Organization(WHO) risk score ≥7
Age≤60 years; female, Chinese women
Initial treatment is chemotherapy
Performance status: Karnofsky score≥60
Laboratory tests: WBC≥3.5×10(9)/L, ANC≥1.5×10(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,blood urea nitrogen, Cr≤ normal
Provide written informed consent.
Patients with unconfirmed diagnosis of GTN
Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
WHO risk score 《7
With severe or uncontrolled internal disease, unable to receive chemotherapy
Concurrently participating in other clinical trials
Unable or unwilling to sign informed consents
Unable or unwilling to abide by protocol
All locations for NCT02639650
Hangzhou, Zhejiang, China
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View full eligibility
Tris trial is registered with FDA with number: NCT02639650. The sponsor of the trial is Weiguo Lv and it is looking for 214 volunteers for the current phase.
Official trial title: A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor
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