Phase II Study of First-line Stereotactic Body Radiation Therapy (SBRT) in Patients With Non-Metastatic Unresectable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of Participants With Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and to find out what effects, good and/or bad, this treatment will have on participants and their cancer.
详细描述
The standard treatment for cancer of the pancreas is surgery (if possible), external beam radiation therapy and/or chemotherapy. These standard treatments are not a cure and often extend life by just a few months. Recently, a new approach has been developed, called stereotactic body radiation therapy (SBRT). Based on the results of earlier studies using SBRT, the study doctors at Moffitt feel this is a reasonable alternative to the standard treatment for your disease.
Stereotactic body radiation therapy (SBRT) delivers high radiation doses to the tumor every day for 5 days which gives the usual 5-6 week course of radiation in less than a week. It has also been shown to have much less side effects.
The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and to find out what effects, good and/or bad, this treatment will have on you and your cancer.
Six patients will be asked to be part of a subgroup called TBRI (Tissue, Blood, Research Imaging). In this subgroup, the investigators want to study if there is early death of tumor cells from the treatment by looking at the tumor using PET/CT scans and biopsies, and by testing your body's white blood cells taken by a procedure called leukapheresis. You do not have to take part in the TBRI subgroup to get treatment on this study with SBRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Overall Survival (OS)
时间窗: 36 Months
Patients will be followed for 36 months to determine overall survival even after completion of the experimental portion of the protocol. Patients will be followed every 3 months. All patients will be referred for chemotherapy at the completion of radiation.
次要结局
- Number of Participants With Reduction in Size of Primary Tumor(12 Months)
- Number of Participants With Adverse Events (AEs)(36 Months)
