Phase I/II Study to Investigate the Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of stereotactic radiation therapy given in five fractions (30 Gray in 5 fractions) followed by gemcitabine in patients with locally advanced pancreatic cancer.
详细描述
The purpose of this phase I/II study is to evaluate the efficacy and toxicity of a different stereotactic body radiation therapy regimen combined with gemcitabine. In the present study, 5 daily fractions of 6 Gray will be given over two weeks. Stereotactic body radiation therapy will be given with the Cyberknife system. This treatment technique allows to give a higher dose to the tumor as compared to conventional external beam radiation while lowering the dose to the normal tissues around. This treatment system is also capable of following the motion that the pancreas assumes during respiration as well as during treatment. This enables us to reduce the margin of security and further reduce dose to surrounding normal tissue.
The primary objective of this study is to evaluate acute and chronic toxicity of this regimen of stereotactic radiation therapy followed by gemcitabine. Quality of life, local control and overall survival will also be evaluated.
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
- •Pancreatic Adenocarcinoma, histologically and/or cytologically proven
- •Locally advanced pancreatic cancer, surgically non resectable
- •No distant metastasis
- •Work-up including medical history, physical exam, biochemistry, chest X-ray, CT-scan of abdomen and pelvis
- •ECOG performance status : ≤ 2
- •Primary tumor visible on CT-scan
- •Maximum tumor diameter of 6 cm (including primary tumor and regional lymph nodes)
- •White blood cell count > 3000 /uL, Neutrophils > 1500 /uL, Platelets > 100 000/uL, Hemoglobin > 95 mg/L, Total bilirubin < 1,5 normal limit, AST/ALT < 2,5 normal limit, normal creatinin
- •≥ 18 years of age
- •Signed informed consent
排除标准
- •Prior abdominal radiation therapy
- •Connective tissue disease (scleroderma, lupus)
- •Prior treatment for pancreatic cancer such as radiation therapy, chemotherapy or surgery.
结局指标
主要结局
Number of participants with adverse events
时间窗: one year
Acute and chronic toxicities will be evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0
次要结局
- Quality of life(3 monthly)
- overall survival(one and two year)
- Local control(3 monthly)