Comparison Between Rescue Regimen and High Dose Methotrexate in the Managment of Presistent Gestational Trophoplastic Neoplasia :( A Randomized Controlled Trial )
试验速览
- 阶段
- 2 期
- 入组人数
- 170
- 主要终点
- cure rate
研究概览
简要总结
Gestational trophoblastic neoplasia (GTN) are malignant lesions that arise from abnormal proliferation of placental trophoblast. The pathologic conditions that make up this entity include invasive partial and complete hydatidiform mole, choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT). GTN often arises after molar pregnancies but can also occur after any gestation including miscarriages and term pregnancies. In the United States, hydatidiform moles are observed in approximately 1/600 therapeutic abortions and 1/1000-2000 pregnancies . Most cases of GTN are diagnosed when the serum hCG levels plateau or rise in patients being observed after the diagnosis of hydatidiform mole.These malignancies are highly susceptible to chemotherapy and it is often possible to achieve cure while preserving the woman's reproductive function
详细描述
When reporting GTN data, it is useful to use both the FIGO anatomic staging system and prognostic scoring system . A FIGO score of 6 or less indicates low-risk GTN whereas a score of 7 or more identifies high-risk disease.
Table 1- FIGO Anatomical staging of gestational trophoblastic neoplasia:
Stage I Disease confined to the uterus Stage II Disease extends to the outside of the uterus, but is limited to the genital structures Stage III Disease extends to the lungs, with or without genital tract involvement Stage IV All other metastatic sites
Table 2- FIGO Scoring system:
FIGO SCORING 0 1 2 4 Age (years) Antecedent pregnancy Interval months from end of index pregnancy to treatment Pretreatment serum hCG (iu/l) Largest tumour size, including uterus Site of metastases Number of metastases Previous failed chemotherapy <40 ≥40 - - mole abortion term <4 4-6 7-12 >12 <1000 1000-10000 10000-100000 >100000 <3cm 3-4cm ≥5 - Lung spleen&kidney GIT liver&brain
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18-50
- •BW: 50-100 kg
- •willing and consenting to be enrolled in the study
- •Absence of active vaginal bleeding which requires surgical intervention • - WHO score <6
排除标准
- •Renal and liver dysfunction or blood dyscariasis
- •high risk persistent gestational trophoblastic disease.
研究组 & 干预措施
study group1
In the rescue regimen , we administer MTX in an eight-day treatment regimen consisting of four administrations of MTX given at 1 mg/kg I.M. every other day with folinic acid 0.1 mg/kg I.M,. given on intervening days.
干预措施: rescue regimen (Drug)
study group2
In the high dose MTX protocol, the patients will receive 100 mg/m2 intravenous (IV) MTX bolus followed by 200 mg/m2IV MTX infused over 12 hours followed by folinic acid
干预措施: high dose methotrxate (Drug)
结局指标
主要结局
cure rate
时间窗: 12 month
cure rate till B hcG is negative and then 2 consolidation regimens
次要结局
- decline in Bhcg(12 month)
研究者
Zahraa Magdy
principal investigator
Assiut University