Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone for Patients With Oligo-metastatic Stage IV Non-small Cell Lung Cancer (NSCLC)
Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone for Patients With Oligo-metastatic Stage IV Non-small Cell Lung Cancer (NSCLC).
研究概览
详细说明
Eligible patients (see below) will receive radical radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/- 1Gy, irrespective of lung function and/or to all metastatic sites to a minimal biological equivalent of 60Gy in 30 daily fractions. This may be delivered with hypofractionated stereotactic techniques or with other more protracted fractionation regimen.
Both the primary tumor, the regional N1 lymph nodes and the oligo-metastatic site(s) may be treated with surgery, as long as an R0 resection is deemed possible. Systemic treatment is not required, but should be given according to the local extend of the tumor.
Local radiotherapy will be delivered according to the protocol of MAASTRO clinic for that anatomical site.
Other dose-constraints: spinal cord max: 54Gy, brachial plexus (Dmax): 66Gy The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Limburg
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Maastricht、Limburg、荷兰、6229 ET
- Maastro clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histological or cytological proven NSCLC
- UICC stage IV, or solitary metastases (< 5), which are amendable for radical local treatment
- Performance status 0-2
- Other malignancy is allowed if controlled at the point of diagnosis
Exclusion Criteria:
- Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
- Stage I-III, except for T4 because of pleural metastases
- Performance status 3 or more
学习计划
研究是如何设计的?
设计细节
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Single arm
Eligible patients
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放疗
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Overall survival
大体时间:2 years
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The survival of participating patient two years after entering the study
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2 years
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Overall survival
大体时间:3 years
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The survival of participating patients, three years after entering the study.
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3 years
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次要结果测量
结果测量 |
大体时间 |
---|---|
无进展生存期
大体时间:2年
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2年
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无进展生存期
大体时间:3年
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3年
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Dyspnea (CTC4.0)
大体时间:2 years
|
2 years
|
Dysphagia (CTC 4.0)
大体时间:2 years
|
2 years
|
Patterns of recurrence
大体时间:2 years
|
2 years
|
Dyspnea (CTC4.0)
大体时间:3 years
|
3 years
|
Dysphagia (CTC4.0)
大体时间:3 years
|
3 years
|
Patterns of recurrence
大体时间:3 years
|
3 years
|
合作者和调查者
调查人员
- 首席研究员:Dirk De Ruysscher, MD, PhD、MAASTRO clinic, Maastricht Radiation Oncology
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
放疗的临床试验
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University Hospital, GhentJules Bordet Institute; AZ Sint-Lucas Gent; GZA Ziekenhuizen Campus Sint-Augustinus; AZ Sint-Lucas...完全的