Primary Surgery Plus Single Course Methotrexate Versus Primary Methotrexate for Treatment of Gestational Trophoblastic Neoplasms in Low Risk Cases Above 40y: a Randomized Controled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML
研究概览
简要总结
Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy especially methotrexate and the investigators try to find a role of surgery plus methotrexate instead of multiple doses and cycles of chemotherapy.
详细描述
Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy espechialy methotrexate and the investigators try to find a role of surgery plus mehotrexate instead of multiple doses and cycles of chemotherapy that affect the patient quality of life and complication related to both line of management and time of decrease of B-hcg.
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •40 years or more
- •plateau or rising B- hCG titre
- •without distant metastasis
- •WHO score is less than 7
排除标准
- •less than 40 years
- •distant metastasis to lung and liver
- •chronic medical diseases
- •WHO score is more than 7
研究组 & 干预措施
surgery and methotrxate
The patient will be treated by total abdominal hystrectomy(after written consent laparatomy will be done then pelvic examination for extra uterine spread, palpation of liver, omentum for any gross lesions and then hystrectomt bilateral salpigooophrectomy will be done) plus single course methotrexate(anti folate chemotheraputic agent, vial form given by intramuscular injection) 1mg/kg alternating with calcium folinate 0.1 mg/kg until normalization of B-HCG
干预措施: Total abdominal hysterectomy and methotrexate (Procedure)
methotrxate
The patient will be treated by multiple courses of methotrexate( antifolate) 1mg/kg every 14 days each one alternating in every otherday with calcium folinate 0.1 mg/kg till normalization of B-HCG
干预措施: Methotrexate plus folinic acid alone (Drug)
结局指标
主要结局
number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML
时间窗: 1-6 months
次要结局
- complications from management(1-6 months)
- quality of life( questionairre)(1-6 months)
- time interval for B-hCG reach less than 5 MU/ML(1-6 months)
研究者
Maher elesawi kamel elesawi
assistant lecturer
Mansoura University