A Phase II Prospective Randomised Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Inoperable Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Survival
研究概览
简要总结
To assess if endoscopic ultrasound-guided radiofrequency ablation application in patients with inoperable pancreatic cancer confers survival benefit when compared to patients receiving standard medical care.
详细描述
The five-year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite of the advances in management of cancers in the last few decades. Endobiliary application of radiofrequency (RF) has been developed and used in patients with inoperable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. (1, 2) Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) of pancreatic neoplasms has been proven to be well tolerated and safe, inducing a significant reduction in tumour size (3). Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection (4). Kahaleh et al. have demonstrated that Endoscopic ultrasound guided RF ablation (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter (EMcision Ltd, UK) through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis (5). In a pilot clinical study, Pai et al showed either a complete response or at least a 50% reduction in tumours following application of radiofrequency ablation with the Habib™ EUS-RFA device in a group of eight patients with pancreatic cancers (3).
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above 18 years of age.
- •A cytological / histological diagnosis of inoperable PDAC based on multidisciplinary review of cross-sectional imaging and cytology / histology results.
- •Patients ought to be fit enough to be considered for the study (ECOG (Eastern Cooperative Oncology Group) performance status 0, 1 or 2)
- •Patients who have commenced chemotherapy are not excluded from the study
- •Patients capable of giving informed consent
- •Negative blood pregnancy test for women of childbearing potential
- •Willingness and ability to comply with all protocol requirements including scheduled visits, treatment plans, laboratory tests and other study procedures.
排除标准
- •ECOG performance status 3 or 4
- •Life expectancy less than 3 months (including liver metastases, carcinomatosis)
- •Prior investigational drugs within the last 30 days
- •Known infection with human immunodeficiency virus (HIV)
结局指标
主要结局
Survival
时间窗: at time of death on average 10months
Duration of survival
次要结局
- Monitoring of Adverse reactions(At time of death on average 10months)
- Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)(Time of death on average 10 months)
- Pain reduction(Time of death on average 10months)
- Tumour Size(4 months)
