Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 发起方
- UMC Utrecht
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
Pancreatic cancer has a very poor survival, due to late diagnosis and lack of sufficient treatment options for locally advanced tumors and metastasized patients. High dose radiotherapy with small margins seems feasible with current technical possibilities, e.g. by fiducial guided stereotactic radiotherapy. In this study, we want to evaluate safety and technical feasibility for cone beam CT guided stereotactic radiotherapy for locally advanced pancreatic carcinoma.
详细描述
Objective of the study:
To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced pancreatic carcinoma
Study design:
Pilot study to determine safety and feasibility
Study population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Locally advanced pancreatic tumors (stage III) or medically inoperable patients with pancreatic cancer (stage I, II, or III)
- •Not eligible for operation with curative intent
- •>18 years
- •Written informed consent
排除标准
- •WHO performance status 3-4
- •Expected life span <3 months
- •Previous chemotherapy, pancreatic surgery or pancreatic radiotherapy
- •Exclusion criteria for contrast enhanced MRI and/or CT scan, following the protocol of the department of radiology UMCU
结局指标
主要结局
Safety
时间窗: 90 days of last irradiation
Safety of the procedure, expressed in proportion of patients experiencing treatment-induced toxicity grade 3 or more according to the CTC-AE 4.0 due to the complete procedure within 90 days of the last radiation
次要结局
未报告次要终点