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

• Status: Unknown status
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weiguo Lv
• Collaborators: First Affiliated Hospital of Zhongshan Medical University; Huazhong University of Science and Technology; Shandong University
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Cyclophosphamide; Dactinomycin; Etoposide; Etoposide phosphate; Methotrexate; Paclitaxel; Vincristine

Criteria

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

• 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 《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