A Randomized Trial of Standard vs. Hypofractionated Accelerated Radiotherapy for Progression in Limited-Stage Small Cell Lung Cancer (SHARP SCLC)
A Randomized Trial of Standard vs. Hypofractionated Accelerated Radiotherapy for Progression in Limited-Stage Small Cell Lung Cancer (SHARP-SCLC)
This study aims to determine whether an abbreviated course of thoracic radiotherapy, delivered in five fractions over one week between chemotherapy cycles, improves progression-free survival compared with standard radiotherapy delivered concurrently with chemotherapy in patients with newly diagnosed limited-stage small cell lung cancer (LS-SCLC).
研究概览
地位
条件
详细说明
This is a multicentre, randomized clinical trial comparing two thoracic radiation therapy (RT) approaches for patients with newly diagnosed limited-stage small cell lung cancer (LS-SCLC).
Standard treatment for LS-SCLC involves chemotherapy combined with thoracic radiation therapy. Conventional radiation schedules require daily or twice-daily treatments over several weeks. This study will investigate whether a shorter, accelerated course of radiotherapy can improve progression-free survival while reducing treatment burden.
The primary outcome is progression-free survival, defined as the time from randomization to disease progression or death. Secondary outcomes include overall survival, treatment-related toxicity, patient-reported quality of life, and treatment burden.
The study also includes exploratory translational research involving blood samples and radiation dosimetric analyses to better understand the biological effects of different radiation schedules.
Participants will be followed for up to five years after randomization to assess short- and long-term outcomes.
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Melody Qu, MD
- 电话号码：519-685-8650
- 邮箱：Melody.Qu@lhsc.on.ca
学习地点
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Ontario
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London、Ontario、加拿大、N6A 5W9
- London Health Sciences Centre, Verspeeten Family Cancer Centre
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接触：
- Melody Qu, MD
- 电话号码：519-685-8650
- 邮箱：Melody.Qu@lhsc.on.ca
-
首席研究员：
- Melody Qu, MD
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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:
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New diagnosis of Limited-stage small cell lung cancer (LS-SCLC), eligible for curative intent concurrent chemoradiotherapy
-- Planned for immunotherapy and prophylactic cranial irradiation is allowed and encouraged
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Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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Age 18 years or older
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Life expectancy > 3 months
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Willingness and ability to provide informed consent
Exclusion Criteria:
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Prior thoracic radiation therapy (RT) which, in the opinion of the treating radiation oncologist, precludes the delivery of further thoracic RT
- If there has been prior thoracic RT, a composite of all RT plans must be created, and the dose constraints herein must still be met
- An allowance for 10% repair is permitted if at least 12 months have passed between the prior RT and the trial protocol specified RT
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Serious medical comorbidities which, in the opinion of the treating radiation oncologist, preclude the delivery of RT
-- This includes interstitial lung disease
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Patients who have started systemic treatment for LS-SCLC but are unable to start radiation with cycle 3 or earlier (delaying scheduled chemotherapy without clinical indication) is not permitted
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Pregnant or lactating women
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Inability to attend the full course of RT or planed follow-up visits
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Standard Thoracic Radiotherapy
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Standard RT using VMAT or IMRT. Accepted standard-of-care fractionation schedules include:
4-6 cycles of intravenous (IV) cisplatin (75 mg/m2) or carboplatin (area under the curve of 5-6 mg/mL × min) given on day 1 or day 1-3 and etoposide (100 mg/m2) on days 1 to 3 every 3 weeks. Oral etoposide (200 mg/m²) is permitted in urgent situations and/or when IV etoposide is not feasible, at the treating clinician's discretion. |
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实验性的：Hypofractionated Accelerated Thoracic Radiotherapy
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4-6 cycles of intravenous (IV) cisplatin (75 mg/m2) or carboplatin (area under the curve of 5-6 mg/mL × min) given on day 1 or day 1-3 and etoposide (100 mg/m2) on days 1 to 3 every 3 weeks. Oral etoposide (200 mg/m²) is permitted in urgent situations and/or when IV etoposide is not feasible, at the treating clinician's discretion. Hypofractionated radiotherapy using VMAT or IMRT, prescribed to a total dose of 35 Gy in 5 fractions, with a SIB to 40 Gy for GTV where feasible. Radiotherapy will begin as early as feasible, preferably during chemotherapy cycle 1 or 2, and no later than cycle 3. Radiation will be delivered between chemotherapy cycles, ideally on days 15-20 of the respective cycle to avoid the anticipated chemotherapy nadir, and will not be administered on chemotherapy treatment days. |
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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Progression-free survival
大体时间：From randomization to disease progression or death, assessed for up to 60 months.
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Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Disease progression will be assessed using RECIST version 1.1 criteria. Participants without documented progression or death will be censored at the date of their last adequate disease assessment. |
From randomization to disease progression or death, assessed for up to 60 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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Changes in Quality of Life Measured by the Functional Assessment of Cancer Therapy: Lung (FACT-L), and EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaires
大体时间：From randomization to 60 months post-randomization
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Changes in quality of life as reported by the participant on the Functional Assessment of Cancer Therapy: Lung (FACT-L) and EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaires |
From randomization to 60 months post-randomization
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Acute and Chronic Physician-Reported Toxicity Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
大体时间：From randomization to 60 months post-randomization
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Severity and grade of side effects of treatment as reported by the physician as grade 2 or greater, using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
From randomization to 60 months post-randomization
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Overall Survival
大体时间：From randomization to 60 months post-randomization
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Overall survival defined as time from randomization to death from any cause, or last follow-up, whichever occurs first |
From randomization to 60 months post-randomization
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Freedom From Intrathoracic Progression
大体时间：From randomization to 60 months post-enrollment
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Freedom From Intrathoracic Progression defined as time from randomization to disease progression with the thorax, or last follow-up, whichever occurs first. |
From randomization to 60 months post-enrollment
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Freedom From Intracranial Progression
大体时间：From randomization to 60 months post-randomization
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Freedom From Intracranial Progression defined as time from randomization to disease progression intracranially, or last follow-up, whichever occurs first. |
From randomization to 60 months post-randomization
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Cost-Effectiveness Analysis
大体时间：From randomization to 60 months post-randomization
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Patient-level data on survival, disease progression, treatment-related toxicity, healthcare utilization, and health-related quality of life (EQ-5D-5L) will inform a cost-effectiveness analysis, based on modelled costs and quality-adjusted life years. |
From randomization to 60 months post-randomization
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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 (估计的)
初级完成 (估计的)
研究完成 (估计的)
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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