Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Lung Cancer: A Single-Blind Randomized Trial
A Single-Blind Randomized Trial of Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Locally Advanced Non-Small Cell and Small Cell Lung Cancer
研究概览
地位
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Feng-Ming Hsu, MD
- 电话号码:67061 +886-2-23123456
- 邮箱:hsufengming@ntuh.gov.tw
学习地点
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Taipei、台湾、100
- 招聘中
- National Taiwan University Hospital
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接触:
- Feng-Ming Hsu, MD
- 电话号码:67061 +886-2-23123456
- 邮箱:hsufengming@ntuh.gov.tw
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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:
- Patients with a histologic diagnosis of non-small cell carcinoma or small cell carcinoma of lung
- Locally advanced stage III A or III B lung carcinoma according to American Joint Committee on Cancer (AJCC) 7th edition or highly selected patients with oligo-metastatic disease amendable for thoracic radiotherapy with curative intent
- Not undergoing radical surgical resection
- Patients do not have prior radiotherapy to the thorax
- Age ≥ 20 years
- Karnofsky performance status (KPS) ≥ 60%.
- Women of childbearing potential and male participants must practice adequate contraception
- Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent
Exclusion criteria:
- Prior radiotherapy to thorax
- Unable to receive assigned radiation dose due to normal lung constraint
- Inability to attend full course of radiotherapy or follow-up visits
- Presence of metastatic disease. Patients who present with oligo-metastatic disease where all metastases have been ablated (with surgery or radiotherapy) or in complete remission after systemic therapy are candidates if they are receiving radiotherapy to the thoracic disease with curative intent
Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
- Uncontrolled active infection requiring intravenous antibiotics at the time of registration
- Transmural myocardial infarction ≤ 6 months prior to registration.
- Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration.
- Life-threatening uncontrolled clinically significant cardiac arrhythmias.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
- Uncontrolled psychiatric disorder.
- Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic.
- Pregnant or lactating women
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Functional Lung Avoidance-TRT
Functional Lung Avoidance Thoracic Radiotherapy The avoidance thoracic radiotherapy treatment plan will be designed to optimize such that radiation dose to functional lung identified by four-dimensional (4D) CT ventilation imaging is as low as reasonably achievable |
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有源比较器:Standard-TRT
Standard Thoracic Radiotherapy The standard thoracic radiotherapy treatment plan will be designed without reference to the functional lung 4D CT ventilation imaging |
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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 |
---|---|---|
The pulmonary quality of life at 3 months post-radiotherapy
大体时间:Change from Baseline Functional Assessment of Cancer Therapy-Lung Cancer Subscale at 3 months
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Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS)
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Change from Baseline Functional Assessment of Cancer Therapy-Lung Cancer Subscale at 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
总生存期
大体时间:从入组之日起至因任何原因死亡之日,评估最长 60 个月
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活着的参加者人数
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从入组之日起至因任何原因死亡之日,评估最长 60 个月
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Changes of pulmonary function test post-radiotherapy
大体时间:At baseline, 3, 6, 12 months, and annually until year 5 post-radiotherapy
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Screening spirometry, diffusion capacity of lung for carbon monoxide
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At baseline, 3, 6, 12 months, and annually until year 5 post-radiotherapy
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Patient reported outcome (Quality of Life questionnaire by Functional Assessment of Cancer Therapy)
大体时间:At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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Functional Assessment of Cancer Therapy-Lung
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At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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Patient reported outcome (Quality of Life questionnaire by EORTC Core)
大体时间:At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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EORTC Quality of Life-Core 30 questionnaire module
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At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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Patient reported outcome (Quality of Life questionnaire by EORTC Lung cancer)
大体时间:At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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EORTC Quality of Life questionnaire -Lung cancer 13
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At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
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Acute toxicity
大体时间:From date of radiotherapy until 90 days after radiotherapy starts
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Common Toxicity Criteria for Adverse Events version 4
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From date of radiotherapy until 90 days after radiotherapy starts
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Late toxicity
大体时间:90 days after radiotherapy starts until the date of death from any cause, up to 60 months
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Common Toxicity Criteria for Adverse Events version 4
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90 days after radiotherapy starts until the date of death from any cause, up to 60 months
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Progression free survival
大体时间:From date of enrollment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months
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Number of participant without disease progression
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From date of enrollment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Serum biomarkers in association with radiation pneumonitis
大体时间:At baseline, 1, 2, 3, 4, 6 months post-radiotherapy
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Tumor necrosis factor-alpha, Transforming growth factor-beta concentration measured by ELISA
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At baseline, 1, 2, 3, 4, 6 months post-radiotherapy
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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