Trial | NCT02639650  Report issue

Title

Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor
A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    214
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.
Gestational trophoblastic tumor (GTN) is a group of malignant tumors derived from placental trophoblastic cells, most of which occur in women of reproductive age. The survival rate of patients with score of 7 or more points, or WHO Ⅳ period for high-risk patients was of 60% to 80%. However, due to severe toxic reactions, long treatment time, loss of optimal reproductive age and increased costs, and treatment failure caused by chemotherapy resistance, high-risk GTN is still one of the tumors seriously affecting the life health and quality of life of young women.

First-line chemotherapy recommended by FIGO is regimen of EMA - CO with corresponding side effects and adverse factors in the following aspects as relatively higer incidence of myelosupression, VP - 16 being associated with a second tumor, especially leukemia, and a definite effect of cyclophosphamide on the failure ovarian function Taxol (Taxol) is the most widely used and most effective broad-spectrum anti-tumor drug in gynecological malignant tumors at present, and T (paclitaxel) +P (platinum drugs) scheme is the first-line chemotherapy scheme in ovarian cancer patients at present. According to references, TP also has effects on resistant and refactory high risk GTN patients.

Given relatively simple operation way of TP chemotherapy, and the effect of chemotherapy in recurrence and high-risk refractory GTN performance,this prospective multicenter randomized controlled clinical research was to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor compared with EMA-CO.
Study Started
Mar 01
2016
Primary Completion
Mar 01
2024
Anticipated
Study Completion
Mar 01
2026
Anticipated
Last Update
Jun 03
2022

Drug Etoposide

etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle

  • Other names: VP-16

Drug actinomycin D

actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle

  • Other names: ACTD, Sanamycin

Drug methotrexate

methotrexate 100mg/m2, 200mg/m2, ivgtt, tetrahydrofolic acid （FA) 15mg q12h*4(24h after methotrexate injection),started at the first day of cycle, two weeks a cycle

  • Other names: MTX

Drug vincristine

vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle

  • Other names: VCR

Drug cyclophosphamide

cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle

  • Other names: CTX

Drug Paclitaxel

paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle

  • Other names: Taxol

Drug Cisplatin

cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle

  • Other names: DDP

Drug Carboplatin

carboplatin area under curve (AUC)=4-5, started at the first day of cycle, two weeks a cycle,as a substitute drug for cisplatin

  • Other names: CBP

control group Active Comparator

etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle

study group Experimental

paclitaxel + cisplatin or carboplatin，two weeks a cycle

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, 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
No Results Posted