Positron Emission Tomography Scan and CT Scan in Planning Radiation Therapy for Patients With Stage II or Stage III Non-Small Cell Lung Cancer
Comparative Study of Gross Tumor Volume Definition With or Without PET Fusion for Patients With Non-Small Cell Lung Carcinoma
RATIONALE: Imaging procedures, such as positron emission tomography (PET) scan and CT scan, may help doctors plan radiation therapy for patients with non-small cell lung cancer.
PURPOSE: This clinical trial is studying how well a combined PET scan and CT scan works compared to a CT scan alone in planning radiation therapy for patients with stage II or stage III non-small cell lung cancer.
研究概览
详细说明
OBJECTIVES:
Primary
- Determine the impact of positron emission tomography (PET)/CT fusion scan and CT scan alone, by comparing gross tumor volume (GTV) contours and three-dimensional conformal radiotherapy treatment plans using 2 separate data sets (PET/CT fusion scan and CT scan only), in patients with stage II or III non-small cell lung cancer who are planning to undergo radiotherapy.
- Determine the impact of PET on GTV (cm^3), number of involved nodes, location of involved nodes, and dosimetric measures of normal tissue toxicity (mean lung dose, V20, and mean esophageal dose).
Secondary
- Determine the rate of elective nodal failures (nodal failures in regions that are not intentionally irradiated to definitive doses [i.e., ipsilateral hilum, mediastinum, or ipsilateral supraclavicular fossa]).
OUTLINE: This is a multicenter study. Patients are stratified according to neoadjuvant chemotherapy (yes vs no).
Patients undergo a combined positron emission tomography (PET)/CT scan. Patients also undergo a CT scan alone. A single three-dimensional conformal radiotherapy (3DCRT) plan is generated from the combined PET/CT scan results. A single 3DCRT plan using the planning target volume is derived from the CT scan only.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Montreal、加拿大、H2W 1S6
- McGill Cancer Centre at McGill University
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Missouri
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St Louis、Missouri、美国、63110
- Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
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Texas
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Dallas、Texas、美国、75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Wisconsin
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Madison、Wisconsin、美国、53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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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
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIA/IIB or stage IIIA/IIIB disease
- Planning to undergo radiotherapy
- Local or regional nodal recurrence after surgery allowed
- No malignant pleural effusion
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent neoadjuvant and/or concurrent chemotherapy allowed
- No concurrent intensity-modulated radiotherapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 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：Arm 1
Two radiation oncologists are randomly assigned to develop either a 3DCRT plan using CT only, or a 3DCRT plan using fused PET/CT
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone
大体时间：Two treatment plans are centrally reviewed to determine the difference in gross tumor volume between the plans
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Two treatment plans are centrally reviewed to determine the difference in gross tumor volume between the plans
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The impact of positron emission tomography (PET)/CT fusion planning on number of contoured lymph nodes vs. planning with CT scan alone
大体时间：Two treatment plans are centrally reviewed to determine the difference in number of contoured lymph nodes between the plans
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Two treatment plans are centrally reviewed to determine the difference in number of contoured lymph nodes between the plans
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The impact of positron emission tomography (PET)/CT fusion planning on location of involved lymph nodes vs planning with CT scan alone
大体时间：Two treatment plans are centrally reviewed to determine the difference in location of involved lymph nodes between the plans
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Two treatment plans are centrally reviewed to determine the difference in location of involved lymph nodes between the plans
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The impact of positron emission tomography (PET)/CT fusion planning on lung V20 vs planning with CT scan alone
大体时间：Two treatment plans are centrally reviewed to determine the difference in lung V20 between the plans
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Two treatment plans are centrally reviewed to determine the difference in lung V20 between the plans
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The impact of positron emission tomography (PET)/CT fusion planning vs planning with CT scan alone on mean esophagus dose
大体时间：Two treatment plans are centrally reviewed to determine the difference in mean esophagus dose between the plans
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Two treatment plans are centrally reviewed to determine the difference in mean esophagus dose between the plans
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Rate of elective nodal failures as assessed by failure in previously uninvolved regional lymph nodes at 2 years
大体时间：From registration to 2 years
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From registration to 2 years
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合作者和调查者
调查人员
- 首席研究员：Jeffrey Bradley, MD、Mallinckrodt Institute of Radiology at Washington University Medical Center
- 学习椅：Jacqueline Brunetti, MD、Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
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
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