NCT01027221已完成不适用
Randomised Phase I/II Trial in Order to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Neoadjuvant Low-Dose-Radiation Therapy in Primarily Resectable Pancreatic Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity
研究概览
简要总结
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximum number of tumor infiltrating T-cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiological diagnosis of resectable pancreatic carcinoma is required prior to treatment. Potentially resectable is defined as no extrapancreatic disease, no evidence (on CT) of involvement of the celiac axis or superior mesenteric artery, no evidence (on CT or MRI) of occlusion of the superior mesenteric vein or superior mesenteric-portal venous confluence.
- •No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan (or MRI)
- •18 years of age or older
- •American Society of Anesthesiologists (ASA)- Performance status of 1 to 3
- •Women of child bearing potential must practice adequate contraception and refrain from breast feeding. Female patients must have a negative pregnancy test within 7 days of treatment
- •Informed consent
排除标准
- •Locally irresectable pancreatic cancer
- •distant metastases
- •medically unfit for surgery
- •Pregnant or lactating women
- •prior chemotherapy or radiation treatment
- •Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
- •Unwillingness to participate or inability to comply with the protocol for the duration of the study
- •Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
- •Participation in other interventional trials
结局指标
主要结局
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity
时间窗: 1 year
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity
次要结局
- expression of migration-relevant adhesion molecules on tumor endothelial cells(2 years)
- local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls(5 years)
- frequencies of tumor-reactive T-cells in blood and bone marrow(2 years)
- expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood(2 years)
- quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months(3 years)
- surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment(1 year)
研究者
研究点 (4)
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