A Safety Study of Intraoperative Radiation Therapy Following Stereotactic Body Radiation Therapy and Multi-agent Chemotherapy in the Treatment of Localized Pancreatic Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Acute post-operative toxicity of targeted IORT
研究概览
简要总结
This study is designed to investigate the safety of intraoperative radiation therapy (IORT) in patients with localized pancreatic cancer undergoing surgical resection after neoadjuvant chemotherapy and stereotactic body radiation therapy (SBRT).
详细描述
Standard of care treatment for patients with non-metastatic pancreatic adenocarcinoma (PDAC) includes chemotherapy and Stereotactic Body Radiation Treatment (SBRT) followed by surgical resection of the tumor with or without Intra-Operative Radiation Therapy (IORT).
There is some evidence from other research studies suggesting that adding radiation treatment during the surgical resection may improve local control of the cancer. The use of IORT plus surgical resection can be used to treat pancreatic cancer and is done on a case by case basis at Johns Hopkins.
The department of Radiation Oncology has developed a program using a High Dose Rate-IORT (HDR-IORT). The HDR-IORT makes it possible to deliver concentrated radiation dose at the surface of the tumor.
Our team has shown in previous studies that the majority of cancer cells that remain after treatment are located around the area of the pancreas called the "Triangle Volume" (TV). This region contains blood vessels, lymphatic vessels, and nerves, and is at high risk of containing cancer cells. This region is difficult to treat with SBRT alone because of being close to normal, healthy organs. Therefore, this study involves using IORT to treat the TV to a therapeutic radiation dose.
The part of the treatment that is considered research is:
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
- •Age > 18 years old
- •Resectable/BRPC/LAPC as defined by NCCN guidelines (Figure 1) as follows confirmed via CT, EUS, or other imaging modalities.
- •ECOG performance status 0-2
- •Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
- •Candidate for SBRT at JHU
- •Upfront treatment with multi-agent chemotherapy
- •Candidate for surgical exploration at JHU
排除标准
- •Previous thoracic/abdominal radiation therapy
- •Unable to receive SBRT at JHU
- •Duodenal invasion detected on imaging which would exclude candidacy for SBRT
- •Tumor located in pancreatic body or tail
- •Unable to undergo Whipple procedure
- •Evidence of disease not localized to the pancreas
- •Any arterial reconstruction during surgery
- •Currently enrolled in another investigational drug or device trial that clinically interferes with this study
- •Unable to comply with study requirements or follow-up schedule
- •Women of child bearing potential or sexually active fertile men with partners who are women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
研究组 & 干预措施
Intra Operative Radiation Therapy (IORT) Group
The IORT group is the single arm of this study. Enrolled patients who undergo standard of care treatment will also receive a study treatment of High Dose Rate (HDR) Intra Operative Radiation Therapy.
干预措施: High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT) (Radiation)
结局指标
主要结局
Acute post-operative toxicity of targeted IORT
时间窗: 3 months
To evaluate acute post-operative toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.
次要结局
- Median local-progression free survival (LPFS) from IORT(36 months)
- Median progression free survival (PFS) from IORT(36 months)
- Median overall survival (OS) from IORT(36 months)
- Late post-operative toxicity of targeted IORT(36 months)