NCT02319408已完成不适用
A Randomized Phase II Study of Radiation Induced Immune Boost in Operable Non-small Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Cluster of differentiation (CD)8+ T cells in resected NSCLC
研究概览
简要总结
Insufficient migration and activation of tumour specific effector T cells seems to be the one important reason for inadequate host anti-tumour immune response. Ionizing radiation can induce a variety of immune responses. The goal of this randomized trial is to assess if a preoperative single fraction low dose radiation is able to improve anti-tumour immune response in operable early stage lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Histologically proven clinical stage I to IIA pulmonary adenocarcinoma
- •Lung tumor is felt to be curatively resectable by the treating physicians
- •Sufficient pulmonary function for lobectomy according to current guidelines
- •The patient is free of distant metastases as confirmed by contrast-enhanced chest and upper abdomen CT-scan and by contrast-enhanced CT or MRI of the brain
- •Age over 50years at the time of consent due to federal radiation protection law
- •In female patients of childbearing potential there must be a negative pregnancy test
- •Eastern Cooperative Oncology Group performance status of 0,1, 2 or 3 at the time of randomization
- •Patients who the investigator believes can and will comply with the requirements of this protocol
- •Written informed consent according to good clinical practise and national/regional regulations
排除标准
- •The patient shows clinical signs of pneumonia
- •The patient receives immunosuppressive drugs (alkylating agents, antimetabolites, methotrexate, azathioprine, mercaptopurine, cytotoxic antibodies, ciclosporin, tacrolimus, sirolimus, interferon, mycophenolate, small biological agents)
- •The patient has been diagnosed with a potential immune mediated disease
- •Elevated blood leukocyte count or erythrocyte sedimentation rate
- •Pregnancy
- •The patient has received any cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy or chemotherapy
- •The patient is diagnosed with a concomitant malignancy and/or has a history of malignancy within the past five years or has had a malignancy that has been in complete remission for less than 5 years
- •The patient needs chronic long term oxygen therapy
- •The patient has undergone splenectomy
- •The patient is known to be HIV positive
- •The patient has an uncontrolled bleeding disorder
研究组 & 干预措施
No radiation
No Intervention
Lobectomy for lung cancer without preoperative radiation
Preoperative radiation
Experimental
Lobectomy for lung cancer with preoperative radiation
干预措施: Preoperative radiation (Radiation)
结局指标
主要结局
Cluster of differentiation (CD)8+ T cells in resected NSCLC
时间窗: 7 days
Frequencies of CD8+ T cells in resected NSCLC tumors determined by immunohistochemistry
次要结局
- T cell subtypes in resected NSCLC(7 days)
研究者
Dr. med. Seyer Safi
Dr. med. Seyer Safi
University Hospital Heidelberg
研究点 (2)
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