Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor

Summary

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.

Eligibility

Inclusion Criteria:

* 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, and less than 13
* 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.

Exclusion Criteria:

* Patients with unconfirmed diagnosis of GTN
* Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
* WHO risk score less than 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

Conditions2

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