A Prospective, Phase II Study Evaluating the Efficacy of Intraoperative Radiotherapy After Neoadjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 3-year local recurrence rate
研究概览
简要总结
This phase II study is designed to investigate the efficacy of intraoperative radiotherapy after neoadjuvant chemotherapy in patients with resectable pancreatic cancer. The purpose of the study is to show the local recurrence rate after neoadjuvant chemotherapy and IORT is superior to that of surgical resection alone from the historical control. A total of 80 patients will be enrolled, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, following neoadjuvant chemotherapy.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed with adenocarcinoma of the pancreas or clinically diagnosed with imaging examinations or tumor markers
- •20 years or older
- •Performance status 0-2 based on Eastern Cooperative Oncology Group (ECOG)
- •Patients with surgically resectable or borderline resectable and advanced pancreatic cancer that can be resected after neoadjuvant chemotherapy
- •Patients who voluntarily decided to participate in this clinical study and signed a written informed consent
排除标准
- •History of previous abdominal irradiation.
- •When the treatment area is not included in the appropriate radiation field according to the judgment of the radiation oncologist or Durgeon
- •Distant metastasis
- •Other systemic conditions that, under the judgment of the attending physician, would be difficult to undergo surgery or radiiotherapy
结局指标
主要结局
3-year local recurrence rate
时间窗: 3 year after intraoperative radiotherapy
A local recurrence is defined as reappearance of cancer in the ipsilateral preserved breast or chest wall. The 3-year local recurrence rate is calculated using the Kaplan-Meier method.
次要结局
- disease free survival(1 year and 2 year after intraoperative radiotherapy.)
- Overall survival(1 year and 2 year after intraoperative radiotherapy.)
- post-operative complication(3 year after intraoperative radiotherapy)
研究者
Yona Cho
Assistant Professor
Gangnam Severance Hospital