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临床试验/NCT01620034
NCT01620034已完成不适用

A Randomized Study of Stereotactic Body Radiotherapy (SBRT) for Lung Tumours Delivered Over 4 Days Versus 11 Days

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年5月最近更新:
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
50
试验地点
2
主要终点
Rate of grade 2 or higher acute toxicity

研究概览

简要总结

Stereotactic Body Radiotherapy (SBRT) has emerged as a new treatment option for peripherally located lung tumours, offering very high rates of tumour eradication, with minimal side effects. Even though this treatment option is being adopted in more and more cancer centres, there is still no consensus about the optimal schedule for the radiation treatment. Generally speaking, most lung SBRT schedules involve delivering 3-4 days of radiation. At the Sunnybrook Odette Cancer Centre, the lung SBRT policy is to deliver 4 days of radiation over 11 days (each treatment given once very 3rd day). However, some centres deliver the same treatment over 4 days in a row (each treatment given once daily over 4 days). There is no evidence from the published literature to suggest that there is any difference in side effects between delivering the SBRT over 4 days versus 11 days. To confirm this, the investigators propose to conduct a comparative (randomized) study to compare these 2 approaches.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pathologic diagnosis of malignancy in the lung (either NSCLC or metastasis)
  • If pathologic diagnosis is not available, there must be evidence of FDG uptake on PET-CT suggestive of malignancy and/or evidence of tumour growth over serial CT scans
  • Clinical stage I lung cancer or solitary lung metastasis located in the periphery away from central mediastinal structures and <=5cm in size
  • Patient deemed suitable for lung SBRT (reasonable performance status, acceptable pulmonary function) by the attending Radiation Oncologist

排除标准

  • 未提供

研究组 & 干预措施

11 Day Arm

Active Comparator

干预措施: Stereotactic Body Radiotherapy (Radiation)

4 Day Arm

Experimental

干预措施: Stereotactic Body Radiotherapy (Radiation)

结局指标

主要结局

Rate of grade 2 or higher acute toxicity

时间窗: Within 4 months after completion of therapy

CTCAE v4.0 will be used to capture radiotherapy toxicity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Patrick Cheung

Radiation Oncologist

Sunnybrook Health Sciences Centre

研究点 (2)

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