Proton Radiation for Resectable Carcinoma of the Pancreas (PC02)
A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas
研究概览
详细说明
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
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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Jacksonville、Florida、美国、32206
- University of Florida Proton Therapy Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Pathologically confirmed adenocarcinoma of the pancreas.
- Patients must have marginally resectable disease.
- Patients with biliary obstruction must have adequate drainage prior to starting chemoradiation.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Proton radiation and chemotherapy
Proton radiation Capecitabine chemotherapy on radiation days Surgery Gemcitabine chemotherapy |
Neoadjuvant Chemotherapy Capecitabine (Xeloda®) 1,000 mg by mouth twice a day 5 days/week (M-F) on radiation days only Proton radiation 50.4 cobalt gray equivalent(CGE) in 28 fractions over 6 weeks Surgery: Gross total resection of primary tumor and regional lymph nodes done 6 weeks after completion of radiation Adjuvant Chemotherapy starting 2-8 weeks after surgery Suggested Regimen: Gemcitabine (Gemzar®) 1,000 mg/m2 IV total of 18 doses
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring within 90 days of treatment start)
大体时间:1 year following the completion of radiation therapy
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1 year following the completion of radiation therapy
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次要结果测量
结果测量 |
大体时间 |
---|---|
Collect and analyze tumor control outcomes
大体时间:1 year following the completion of radiation therapy
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1 year following the completion of radiation therapy
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合作者和调查者
调查人员
- 首席研究员:Romaine C Nichols, MD、University of Florida Proton Therapy Institute
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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