Locally Invasive NSCLC Treated With NEo-Adjuvant Stereotactic Body RadioTherapy and REsection (LINNEARRE-I)
Phase I Study: Locally Invasive NSCLC Treated With NEo-Adjuvant Stereotactic Body Radiotherapy and REsection
Despite improved staging and operative techniques, the rate of incomplete resection (R1) of NSCLC has remained significant over the last decades. Patients with R1 resection have significantly worse survival compared to those with complete resection (R0).
This is a phase I study that investigates the feasibility and safety of delivering Stereotactic Body Radiotherapy (SBRT) to patients with locally invasive NSCLC (cT3-4, N0-1) who are at risk for incomplete resection.
Twenty patients with NSCLC will be treated with SBRT followed by surgery and appropriate adjuvant therapy. Patients will be divided into groups, of 5 patients each, treated with escalating doses (35, 40, 45 and 50 Gy) in 10 daily fractions.
The primary outcome is the feasibility i.e. the ability to complete safely SBRT and surgery (within 6 weeks). Secondary outcomes include acute and late adverse events, R0/R1/R2 rates and secondary surrogates of feasibility.
If successful, this study will lead to further evaluation of pre-operative SBRT in NSCLC.
研究概览
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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Hamilton、Ontario、加拿大、L8V 5C2
- 招聘中
- Juravinski Cancer Centre
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接触：
- Theos Tsakiridis, MD PhD
- 电话号码：64704 905-308-3574
- 邮箱：tsakirid@HHSC.CA
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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 will be included if they are aged 18 years or older,
- with biopsy proven NSCLC,
- clinically staged T3-T4 marginally resectable i.e. deemed at risk to achieve <R0 resection (such as invasion of critical mediastinal or hilar structures, nodal extra-capsular extension, chest wall, vertebral bodies, compromised bronchial stump margin, based on CT images of the chest).
- Patients also need to be pathologically staged N0-1 disease,
- with an SBRT CTV≤200cm3, based on planning CT images.
- ECOG status is required to be <2 within 4 weeks prior to registration and
- patients must be deemed medically operable by the surgical team.
Exclusion Criteria:
- Patients will be excluded if they are deemed medically inoperable by the surgical team
- and have a weight loss of ≥10% within 3 months prior to pathological diagnosis.
- Patients will also have no absolute contraindication to RT such as connective tissue disease, pacemaker-dependent patient with the pacemaker receiving higher than tolerance dose, had no had previous RT to the current region of the study, that would result in overlap of RT fields,
- patients must have no plans to receive other local therapy while on study, except at disease progression,
- patients have not had other malignancy within 2 years prior to the study (other than non-melanomatous skin cancers)
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：Neoadjuvant stereotactic body radiation
Single arm study.
Four cohorts of 5 patients will undergo neo-adjuvant SBRT for lung cancer.
Eligible patients will have operable, borderline resectable lung cancer , they will be treated with SBRT, prior to undergoing surgical resection.
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Dose escalation of neo-adjuvant SBRT in operable patients with locally advanced non-small cell lung cancer. The first cohort will be treated with a dose of 35 Gy in 10 fractions, the second cohort will be treated with a dose of 40 Gy in 10 fractions, the third cohort will be treated with a dose of 45 Gy in 10 fractions, the fourth cohort will be treated with a dose of 50 Gy in 10 fractions. The SBRT doses will be escalated only once all patients in the previous cohort will have completed safely their treatments. |
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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Feasibility of SBRT followed by surgery (proportion of patients who can undergo 10 fractions of SBRT followed by Surgery)
大体时间：18 months
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Feasibility of neo-adjuvant SBRT followed by surgery.
This will be measured as the proportion of patients who can undergo 10 fractions of SBRT followed by Surgery as scheduled (within 6 weeks from registration).
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18 months
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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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Early safety of SBRT-S through collection of serious adverse events (CTCAE version 4.0 grade 3 or higher) from beginning of SBRT to 4 weeks after completion of surgery.
大体时间：18 months
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18 months
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Late safety profile of SBRT-S through collection of surgical complication rates assessed at 6 and 18 months post-registration (thus 30 months from opening of the study, assuming it takes 1 year to complete accrual).
大体时间：30 months
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Complications recorded include incidence of bronchopleural fistula, esophageal fistula, wound healing complications (dehiscence, infection) and post-operative pulmonary complications).
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30 months
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Secondary feasibility outcomes (including accrual rate, consent rate, rates of deviation from scheduled treatment plan, and reasons for delay)
大体时间：18 months
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These include accrual rate, consent rate, rates of deviation from scheduled treatment plan of 6 weeks, and reasons for delay)
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18 months
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Pathological response following neoadjuvant SBRT (proportion of R0, R1 and R2 resections)
大体时间：18 months
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To determine the proportion of R0, R1 and R2 resections after neoadjuvant SBRT.
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18 months
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Pathologic changes associated with neo-adjuvant SBRT with analysis of irradiated tissues
大体时间：18 months
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18 months
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合作者和调查者
调查人员
- 首席研究员：Theodoros Tsakiridis, M.D., Ph.D.、Juravinski Cancer Center
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 (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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