MRI-guided Dose Intensification Program Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Overall Survival
研究概览
简要总结
The goal of this clinical trial is to learn if the use of dose-escalated MRI-guided irradiation increases the rates of disease control in patients with pancreatic cancer
详细描述
The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Pancreatic Cancer Intensification Program maximizes treatment objectives rates due to the better visualization and online dose-adaptation pancreatic tumor.
Rationale In the radiation setting, MRI provides superior soft tissue contrast compared to standard onboard X-ray imaging improving inter- and intra- observer delineation variation. MRgRT offers the opportunity to adapt the plan at each fraction to the anatomical changes seen (Henke et al., 2018). This creates a much better CTV to OAR ratio in a 50Gy/5Rx scenario.
Primary Objectives A. To achieve a 1-year survival of 85%. B. To decrease grade 4-5 gastrointestinal events to less than 5%.
Secondary Objectives A. Determination of blood and urine biomarkers of treatment response and toxicity .
B. Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of quality of life with the EORTC QLQ-C30 Questionnaire .
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Selection criteria includes patients with unresectable and borderline resectable and medically inoperable pancreatic cancer that will receive neoadjuvant chemotherapy followed by chemoirradiation.
- •No prior radiation therapy to the target areas;
- •Karnofsky performance status > 70 with medical condition not contraindicating treatment with radical intent including neoadjuvant chemotherapy followed by chemoirradiation.
- •WBC equal or greater than 3500 mm^3; platelet count equal or greater than 135000 mm^3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0.
排除标准
- •Inability to undergo an MRI scan
研究组 & 干预措施
Ultrahypofractionation Phase
MR-Guided Ultrahypofractionation
干预措施: MR-guided Irradiation (Radiation)
结局指标
主要结局
Overall Survival
时间窗: 2-years
A. To achieve a 1-year survival of 85%.
次要结局
- Adverse Events(2-years)