A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer
Stereotactic ablative radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment.
The study combines SABR and surgery to treat non-small cell lung cancer. SABR will be done first, with surgery done approximately 10 weeks later. There will be some extra imaging done before and after the SABR.
The purpose of this study is to determine how effective SABR is in killing the cancer cells, and if SABR can help make surgery more effective.
研究概览
详细说明
The advent of stereotactic ablative radiotherapy (SABR) has provided a novel, promising treatment for patients with early-stage non-small cell lung cancer. SABR uses modern radiotherapy planning and targeting technologies to precisely deliver larger, ablative doses of radiotherapy.
The use of SABR as neoadjuvant therapy prior to surgery may provide a novel therapeutic opportunity. In oncology, the use of neoadjuvant radiotherapy or chemoradiotherapy prior to surgery has become widespread for several types of cancer, and in many instances improves local control over and/or survival compared to surgery alone. Neoadjuvant radiotherapy provides several theoretical advantages, including potentially decreasing the rate of positive margins, decreasing the size of the required resection, or by sterilizing the tumor to avoid seeding of circulating tumor cells during surgery. Although radiologic outcomes after SABR illustrate local control rates of approximately 90% in many studies, the presence of residual post-treatment fibrosis may confound this assessment of recurrence.
The goal of this study is to evaluate a novel treatment approach: the combination of neoadjuvant SABR followed by surgical resection in patients with T1T2N0 non-small cell lung cancer, in order to measure the true pathologic rates of local control after SABR, to develop new imaging biomarkers or response, and to assess clinical outcomes, including toxicity, relapse patterns, and survival.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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London、Ontario、加拿大、N6A 4L6
- London Regional Cancer Program of the Lawson Health Research Institute
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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:
- Age 18 or older
- Willing to provide informed consent
- Histologically confirmed non-small cell lung cancer
- Tumor stage T1 or T2a (less than or equal to 5 cm)
- No evidence of nodal disease (N0)
- No evidence of distant metastases (M0)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy > 6 months
- Adequate forced expiratory volume at one second (FEV1), defined as a predicted post-operative FEV1 of 30% or greater
Exclusion Criteria:
- Serious medical comorbidities or other contraindications to radiotherapy or surgery
- Prior history of lung cancer within 5 years
- Prior thoracic radiation at any time
- Inability to attend full course of radiotherapy, surgery, or follow-up visits
- Contrast allergy
- 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：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 |
|---|---|
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实验性的：Stereotactic Body Radiation Therapy plus Surgery
Stereotactic body radiation therapy followed by surgical resection
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Stereotactic body radiation therapy followed by surgical resection
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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 |
|---|---|---|
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Tumor response
大体时间：2.5 years
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Percentage of patients who exhibit a lack of viable tumor after surgical resection
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2.5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Predictive value of imaging biomarkers
大体时间：2.5 years
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Predictive value of novel imaging biomarkers compared to pathologic outcome (complete response or non-complete response to treatment)
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2.5 years
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Tumor recurrence
大体时间：7 years
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Time to local recurrence, regional recurrence, and distant recurrence of disease will be measured
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7 years
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Toxicity of the combined approach of SABR + surgery
大体时间：7 years
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Toxicity of the combined approach of SABR plus surgical resection will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.
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7 years
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Quality of life measures , including physical well-being, functional well-being, and lung-cancer subscale questions
大体时间：7 years
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The FACT-TOI is a summary score derived from the FACT-L and is composed of 21 items, including physical well-being, functional well-being, and lung-cancer subscale questions
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7 years
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合作者和调查者
调查人员
- 首席研究员：David Palma, MD, PhD、London Regional Cancer Program of the Lawson Health Research Institute
出版物和有用的链接
一般刊物
- Yang DM, Palma DA, Kwan K, Louie AV, Malthaner R, Fortin D, Rodrigues GB, Yaremko BP, Laba J, Gaede S, Warner A, Inculet R, Lee TY. Predicting pathological complete response (pCR) after stereotactic ablative radiation therapy (SABR) of lung cancer using quantitative dynamic [18F]FDG PET and CT perfusion: a prospective exploratory clinical study. Radiat Oncol. 2021 Jan 13;16(1):11. doi: 10.1186/s13014-021-01747-z.
- Palma DA, Nguyen TK, Louie AV, Malthaner R, Fortin D, Rodrigues GB, Yaremko B, Laba J, Kwan K, Gaede S, Lee T, Ward A, Warner A, Inculet R. Measuring the Integration of Stereotactic Ablative Radiotherapy Plus Surgery for Early-Stage Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial. JAMA Oncol. 2019 May 1;5(5):681-688. doi: 10.1001/jamaoncol.2018.6993.
- Palma DA, Nguyen TK, Kwan K, Gaede S, Landis M, Malthaner R, Fortin D, Louie AV, Frechette E, Rodrigues GB, Yaremko B, Yu E, Dar AR, Lee TY, Gratton A, Warner A, Ward A, Inculet R. Short report: interim safety results for a phase II trial measuring the integration of stereotactic ablative radiotherapy (SABR) plus surgery for early stage non-small cell lung cancer (MISSILE-NSCLC). Radiat Oncol. 2017 Jan 27;12(1):30. doi: 10.1186/s13014-017-0770-7.
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 (估计)
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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非小细胞肺癌的临床试验
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Taichung Veterans General Hospital完全的心脏毒性 | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung） | 药物相关副作用和不良反应（MeSH术语） | 表皮生长因子受体酪氨酸激酶抑制剂台湾
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Fondazione del Piemonte per l'Oncologia招聘中乳腺癌 | 卵巢癌 | 结直肠癌 | 黑色素瘤（皮肤癌） | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung）意大利