A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to 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 and chemotherapy has on you and your pancreatic cancer.
详细描述
Chemotherapy:Capecitabine on radiation days
Proton radiation over 7 weeks
Consolidation Chemotherapy:Gemcitabine
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 100 Years（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 be medically inoperable or have unresectable disease
排除标准
- •Evidence of distant metastasis; evidence of metastatic disease in the major viscera (organs), peritoneal seeding and/or ascites.
- •Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
- •Prior surgical resection.
研究组 & 干预措施
Proton radiation and chemotherapy
Chemotherapy and Radiation Combination
Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.
Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.
Consolidation Chemotherapy starting 4 weeks after the completion of radiation
Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.
干预措施: Proton radiation and chemotherapy (Radiation)
结局指标
主要结局
Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to 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 Measures(1 year following the completion of radiation therapy)