A Non-Inferiority Prospective Randomized Multicenter Clinical Control Study of Hysteroscopic Repeat Curettage as the Primal Management of Low-risk Postmolar Gestational Trophoblastic Neoplasia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- complete remission rate in firstline treatment
研究概览
简要总结
Study of hysteroscopic repeat curettage as the first-line treatment in low-risk postmolar gestational trophoblastic neoplasia compared with the MTX single drug chemotherapy
详细描述
Gestational trophoblastic neoplasia (GTN) is a group of malignant tumors derived from placental trophoblastic cells, most of which are secondary to hydatidiform mole, and 95% of GTN patients present low-risk gestational trophoblastic neoplasia(LR-GTN).In the 1960s and 1970s, with the in-depth study of the disease, it was found that the malignant tumor was highly sensitive to chemotherapy and had ideal tumor marker HCG to guide the treatment and follow-up. Therefore, GTN was the best malignant tumor with the overall cure rate of LR-GTN nearly 100%.MTX single-drug multi-course chemotherapy is the classic treatment of LR-GTN recommended by FIGO, but most patients can develop gastrointestinal, blood and liver toxicity during chemotherapy. In addition, the longer treatment cycle also brings a lot of discomfort to patients.
In recent years, some scholars proposed that the selection of treatment regimen of LR-GTN secondary to hydatidiform pregnancy should consider the toxic and side effects of chemotherapy, the maintenance of patients' physiological functions and quality of life.Retrospective studies abroad have shown that LR-GTN delayed chemotherapy for hydatidiform mole pregnancy only started chemotherapy for LR-GTN at a certain stage of progression, and the results did not change the prognosis of LR-GTN but reduced the rate of chemotherapy.In addition, for some patients with ultra-low risk of LR-GTN in hydatidiform pregnancy undergoing hysteroscopic repeat curettage , the rate of chemotherapy can be reduced, the related costs can be reduced and the quality of life of patients can be improved.
In this non-Inferiority prospective, multicenter, randomized, controlled clinical study, with the routine use of a gleam of MTX single drug treatment scheme for comparison, comparing uterine cavity again emptying delay chemotherapy guided by parallel hysteroscopy surgery clinical curative effect and adverse reaction, which discuss after hydatidiform mole ultra-low dangerous GTN patients with uterine cavity emptying again guided by hysteroscopy surgery as a line of ultra low dangerous GTN patients after hydatidiform mole security and feasibility of the treatmen
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •low-risk postmolar gestational trophoblastic neoplasia (GTN)
- •World Health Organization(WHO) risk score≤4
- •Age≤60 years; female, Chinese women
- •Initial treatment
- •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 ≥5 分
- •The diameter of a single metastatic lesion in the lung was ≥2cm
- •The number of lung CT metastases was≥ 5
- •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
study group
hysteroscopic repeat curettage
干预措施: hysteroscopic repeat curettage (Procedure)
chemotherapy
Methotrexate 0.4mg/kg·d, im ,*5d started at the first day of cycle, two weeks a cycle
干预措施: Methotrexate (Drug)
结局指标
主要结局
complete remission rate in firstline treatment
时间窗: 2 years
The investigators may calculate the rate of complete response at the preliminary end point of the trail
The ultimate complete response rate
时间窗: 2 years
The investigators may calculate the ultimate complete response rate, defined as the proportion of patients who achieve sustained normalisation of serum hCG without requiring escalation to multi-agent chemotherapy at the predefined trial endpoint.
次要结局
- Menstrual cycle resuming rate(2 years)
- Complications of hysteroscopic repeat curettage surgery(2 years)
- Severity of adverse events as assessed by the WHO(2 years)
- Overall Survival Rate (OR)(2 years)
- Ovarian functional evaluation(2 years)
- The pregnancy rate(2 years)
- chemotherapy-sparing rate(2 years)