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临床试验/NCT02639650
NCT02639650招募中3 期

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

Weiguo Lv1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2016年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
214
试验地点
1
主要终点
complete remission rate in firstline treatment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 60 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

control group

Active Comparator

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

干预措施: Etoposide (Drug)

control group

Active Comparator

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

干预措施: actinomycin D (Drug)

control group

Active Comparator

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

干预措施: methotrexate (Drug)

control group

Active Comparator

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

干预措施: vincristine (Drug)

control group

Active Comparator

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

干预措施: cyclophosphamide (Drug)

study group

Experimental

paclitaxel + cisplatin or carboplatin,two weeks a cycle

干预措施: Paclitaxel (Drug)

study group

Experimental

paclitaxel + cisplatin or carboplatin,two weeks a cycle

干预措施: Cisplatin (Drug)

study group

Experimental

paclitaxel + cisplatin or carboplatin,two weeks a cycle

干预措施: Carboplatin (Drug)

结局指标

主要结局

complete remission rate in firstline treatment

时间窗: 3 years

We may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.

次要结局

  • The pregnancy rate(3 years)
  • Overall Survival Rate (OR)(3 years)
  • Severity of adverse events as assessed by the WHO(3 years)
  • Ovarian functional evaluation(every 6 months up to 3 years)

研究者

发起方
Weiguo Lv
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Weiguo Lv

Vice-President

Women's Hospital School Of Medicine Zhejiang University

研究点 (1)

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