A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring within 90 days of treatment start)
研究概览
简要总结
The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will look at the side effects from the treatment and the quality of your life in relation to pain. It will also look at how the tumor responds to the combination of treatment with radiation, chemotherapy and surgery.
详细描述
Chemotherapy capecitabine on radiation days
Proton radiation over 6 weeks
Surgery 6 weeks after radiation completion
Adjuvant Chemotherapy starting 2-8 weeks after surgery with Gemzar
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
- •Pathologically confirmed adenocarcinoma of the pancreas.
- •Patients must have marginally resectable disease.
- •Patients with biliary obstruction must have adequate drainage prior to starting chemoradiation.
排除标准
- •Evidence of distant metastasis including peritoneal seeding and/or ascites.
- •Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
- •Prior surgical resection.
- •Gastroduodenal obstruction
研究组 & 干预措施
Proton radiation and chemotherapy
Proton radiation
Capecitabine chemotherapy on radiation days
Surgery
Gemcitabine chemotherapy
干预措施: Proton radiation and chemotherapy (Radiation)
结局指标
主要结局
Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring within 90 days of treatment start)
时间窗: 1 year following the completion of radiation therapy
次要结局
- Collect and analyze tumor control outcomes(1 year following the completion of radiation therapy)