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临床试验/NCT03885388
NCT03885388Unknown2 期

Women's Hospital, Zhejiang University School of Medicine

Women's Hospital School Of Medicine Zhejiang University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年3月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
300
试验地点
1
主要终点
primary complete remission

研究概览

简要总结

In this study, a prospective, multicenter randomized controlled study was conducted to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with standard MTX single-drug multi-course regimen.

详细描述

The improved prognostic scoring system has been in use for more than 20 years in GTN patients. However, there are also more and more clinical evidences showing that the International Federation of Obstetrics and Gynecology(FIGO)/world health organization (WHO) system is not so perfect. The main problem is that a considerable number of patients are resistant to initial chemotherapy, 25-35% occur in low risk (≤ 6 points), and 70-80% occur in patients with a score of 5-6 points. According to reference, the drug resistance factors include high HCG level before chemotherapy, metastatic foci, histological diagnosis of choriocarcinoma, etc. However, according to the score before 2000, there is a moderate risk score group with 4-6 points, i.e. most of the single drug resistance to the initial regimen occurs in the previous moderate risk score group.Therefore, most scholars believe that there are grey areas with a score of 5-6. According to the analysis of 5-6 scores in the scoring system, the prognosis of single-drug chemotherapy is poor, and the initial remission rate is only about 30-40%. Therefore, many authors call for the current staging scoring system to be revised to a more accurate model so that some patients who may be drug resistant can adopt more effective plans at the beginning of treatment.

In this study, the investigators plan to conduct a prospective, multicenter randomized controlled study to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with standard MTX single-drug multi-course regimen. The experiment arm of the trial is multi-course combination of MTX and ACTD. The primary endpoint is complete remission rate of primary treatment or failure of primary treatment. Drug toxicity is surveillanced.

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
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical diagnosis of gestational trophoblastic tumor;
  • Patients with prognosis score of 5 and 6
  • Primary chemotherapy (preventive chemotherapy is not included);
  • Physical strength grade: Karnofsky score ≥ 60;
  • WBC ≥ 3.5× 109/L, ANC ≥ 1.5× 109/L, PT ≥ 80× 109/L, serum bilirubin ≤ 1.5 times of normal high limit, transaminase ≤ 1.5 times of normal high limit, BUN, Cr≤ normal;
  • Follow-up and good compliance;
  • Sign the informed consent form.

排除标准

  • Pathological diagnosis is intermediate trophoblastic tumor, including PSTT and ETT;
  • There are serious or uncontrollable medical diseases, which are not suitable for chemotherapy;
  • Those who receive clinical trials of other drugs at the same time.
  • Those who receive Chinese medicine.

研究组 & 干预措施

control arm

Active Comparator

single methotrexate multicourse treatment MTX:MTX 0.4mg/kg•d, intramuscular, every two weeks

干预措施: MTX (Drug)

experimental arm

Experimental

combination of methotrexate and actinomycin multicourse treatment, every two weeks MTX+ACTD:Act-d 0.6mg/m2 Day1,2 intravenous (IV) MTX 100mg/m2 IV Day1(after Act-d) MTX 200mg/m2 Ivgtt Day1(after MTX,500mlNS)

干预措施: MTX+ACTD (Drug)

结局指标

主要结局

primary complete remission

时间窗: 24 weeks

complete remission rate by primary treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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