NCT01342354已完成1 期
A Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (Phase 1)
研究概览
简要总结
This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Patients must have histologically confirmed, unresected cancer of the pancreas or ampulla. The cancer may include any invasive histology (e.g. adenocarcinoma, neuroendocrine carcinoma).
- •Patients must have measurable radiographic disease.Patients with previous complete resection are only eligible if there is measurable radiographic disease which is clearly felt to represent locally recurrent disease.
- •Patients may receive any number of cycles of chemotherapy prior to treatment with SBRT, but not within 2 weeks of the first fraction of RT.
- •Age > or = 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (Karnofsky > or = 60%)
- •Life expectancy of greater than 3 months.
- •Patients must have normal organ and marrow function.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Concurrent investigational therapy delivered over the period of treatment or observation (28 days post-RT) for dose limiting toxicity.
- •Prior radiation therapy to the abdominal area which would overlap with the proposed area of treatment.
- •Pregnancy.
- •Primary disease > 7.5 cm in largest diameter as measured by CT or MRI.
- •Gross extension of tumor into the lumen of the duodenum.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy within 3 months before RT or 6 months after RT.
结局指标
主要结局
Maximum Tolerated Dose (Phase 1)
时间窗: 28 days
Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.
次要结局
- The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity(12 months after treatment)
- Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale(12 months after treatment)
- Number of Patients Eligible for Surgery to Remove Tumor After Treatment(12 months after treatment)
- Number of Patients With Local Disease Control(12 months after treatment)
- Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire.(12 months after treatment)
研究者
研究点 (2)
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