Impact of Second Uterine Evacuation in Women With Non-metastatic, Low-risk Gestational Trophoblastic Neoplasia: A Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Remission rate from primary therapy
研究概览
简要总结
To evaluate the efficacy and safety of second uterine curettage in patients with low-risk non-metastatic GTN.
详细描述
This is a randomized, multicenter clinical trial including patients seen at one of 13 gestational trophoblastic disease reference centers in Brazil. Subjects are eligible if they have low-risk gestational trophoblastic neoplasia according to FIGO 2000 criteria and the FIGO/WHO prognostic risk score. The study includes two treatment arms: immediate treatment with single-agent chemotherapy (center choice of agent) or second uterine curettage. The primary outcome is the rate of primary remission. Secondary outcomes are the number of chemotherapy cycles required to achieve remission, rate of primary chemotherapy resistance, rate of relapse, and overall survival.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Treatment assignments are made by a remote investigator not involved in the clinical care of the patient using a coded key with random block sizes.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histopathological diagnosis of molar pegnancy according to the morphological criteria described by Sebire et al., who meet the diagnostic criteria for low-risk non-metastatic GTN according to FIGO 2000 criteria
排除标准
- •High risk GTN (FIGO risk score ≥ 7) or metastatic disease at diagnosis of GTN (stage II, III or IV);
- •Histopathological diagnosis of choriocarcinoma, placental site trophoblastic or epithelioid trophoblastic tumor at the second curettage;
- •Previous chemotherapy treatment;
- •Level of hCG at the time of GTN diagnosis less than 20 IU/L (to minimize the risk of inclusion of patients with false positive hCG, either by cross-reaction with pituitary hormones or by the presence of circulating heterophilic antibodies);
- •Relapsed GTN;
- •Incomplete medical records.
- •Loss to follow-up;
- •Voluntary desire to stop participating in the study.
研究组 & 干预措施
Chemotherapy
Patients allocated to receive conventional chemotherapy will be treated with methotrexate (1 mg/kg intramuscular) with rescue of folinic acid (15mg orally). In cases of chemoresistance, second-line chemotherapy will be performed with actinomycin-D (Act-D) 1.25 mg intravenous pulse every 14 days. The third line of chemotherapy will be the EMA/CO regimen (reserving the EP / EMA regimen (E, cisplatin, MTX / Act-D) for the fourth line.
干预措施: Chemotherapy (Drug)
Uterine evacuation
Patients randomized to undergo a second curettage will undergo manual or electronic vacuum aspiration under ultrasound guidance. Following discharge after the second curettage patients will return to weekly hCG monitoring. If hCG levels are decreasing, patients will remain on weekly hCG follow-up until the first normal hCG (<5 IU/L) is achieved. Then they will have monthly hCG monitoring for 12 months. If patients do not attain remission and develop persistent GTN as established by FIGO 2000, the tumor will be re-staged and appropriate chemotherapy will be initiated.
干预措施: Uterine curettage (Procedure)
结局指标
主要结局
Remission rate from primary therapy
时间窗: 3 years
Undetectable hCG on weekly serum assay for at least three weeks
次要结局
- Cycles to remission(3 years)
- Death(1 year)
- Time to remission(3 years)
- Need for multiagent chemotherapy(3 years)
- Relapse(1 year)
研究者
Kevin Elias
Co-investigator
Brigham and Women's Hospital