Comparative Study of Gross Tumor Volume Definition With or Without PET Fusion for Patients With Non-Small Cell Lung Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- The impact of positron emission tomography (PET)/CT fusion planning on lung V20 vs planning with CT scan alone
研究概览
简要总结
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.
详细描述
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]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: computed tomography (Procedure)
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
干预措施: positron emission tomography (Procedure)
结局指标
主要结局
The impact of positron emission tomography (PET)/CT fusion planning on lung V20 vs planning with CT scan alone
时间窗: Two treatment plans are centrally reviewed to determine the difference in lung V20 between the plans
The impact of positron emission tomography (PET)/CT fusion planning on location of involved lymph nodes vs planning with CT scan alone
时间窗: Two treatment plans are centrally reviewed to determine the difference in location of involved lymph nodes between the plans
The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone
时间窗: Two treatment plans are centrally reviewed to determine the difference in gross tumor volume between the plans
The impact of positron emission tomography (PET)/CT fusion planning on number of contoured lymph nodes vs. planning with CT scan alone
时间窗: Two treatment plans are centrally reviewed to determine the difference in number of contoured lymph nodes between the plans
The impact of positron emission tomography (PET)/CT fusion planning vs planning with CT scan alone on mean esophagus dose
时间窗: Two treatment plans are centrally reviewed to determine the difference in mean esophagus dose between the plans
次要结局
- Rate of elective nodal failures as assessed by failure in previously uninvolved regional lymph nodes at 2 years(From registration to 2 years)