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临床试验/NCT03444948
NCT03444948暂停不适用

A Phase II Prospective Randomised Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Inoperable Pancreatic Ductal Adenocarcinoma

Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2019年2月14日最近更新:
适应症

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

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)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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