Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Local Control Rate
研究概览
简要总结
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.
详细描述
This is a single institution, non-randomized, prospective, phase IV trial of SBRT for unresectable pancreatic cancer.
Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.
Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
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
- •Patient age >= 18 years
- •Performance status of 0-3
- •Unresectable pancreatic cancer
- •Maximum tumor diameter < 7.5 cm
- •Signed study-specific consent form
排除标准
- •Maximum tumor diameter > 7.5 cm
- •Prior radiotherapy to the upper abdomen
- •Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
- •Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
结局指标
主要结局
Local Control Rate
时间窗: 5 years
Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of \> 20% in tumor size. If necessary, a Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence.
次要结局
- Late Toxicity Rate(5 years)
研究者
Kathy Baglan, MD
Radiation Oncologist
Mercy Research