Fludeoxyglucose F 18 PET/CT Scans in Predicting Therapy Response in Patients With Stage IIIA Non-Small Cell Lung Cancer Undergoing Chemoradiation
Open Label Randomized Trial of Early Assessment of Therapy Response Using 18FDG-PET/CT in Patients With Marginally Resectable Stage IIIA (N2) Non-Small Cell Lung Cancer (NSCLC) Treated With Induction Concurrent Chemoradiation Followed by Resection and Adjuvant Chemotherapy
研究概览
地位
条件
详细说明
PRIMARY OBJECTIVES:
I. To determine whether early response of the research positron emission tomography (PET)-computed tomography(CT) scan measured by change in Standard Uptake Value (SUV)max relative to baseline scan can predict induction chemoradiation therapy (CRT) failures sooner than post-treatment PET-CT scan.
II. To determine the optimal timing for 18FDG PET-CT that best predicts for induction CRT failure.
SECONDARY OBJECTIVES:
I. To correlate early 18 fludeoxyglucose (FDG) PET-CT response metrics with pathologic response, progression-free survival separately for: induction CRT failures vs. non-failures, or overall survival separately for induction CRT failures vs. non-failures.
OUTLINE: Patients are randomized to 1 of 3 groups.
Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.
GROUP A: Patients undergo a FDG PET/CT scan between RT fractions 5-6 (before course 2 of chemotherapy).
GROUP B: Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of chemotherapy).
GROUP C: Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of chemotherapy).
Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.
研究类型
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All patients with marginally resectable IIIA (N2) NSCLC undergoing induction CRT will be eligible for this imaging trial; patients will be screened by the chest tumor board for entry
- Undergoing or plan to undergo induction chemoradiation
Exclusion Criteria:
- Poorly controlled or uncontrolled diabetes mellitus, with blood glucose > 200 mg/dl
- Have allergies or medical contra-indications to FDG or intravenous (IV) contrast
- Medical contra-indications to obtaining CT or PET scans
- Pre-authorization denial of coverage by insurance providers of clinical staging and restaging PET-CT scans
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 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 |
|---|---|
|
实验性的：Group A (FDG PET/CT between RT fractions 5-6)
Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy. Patients undergo a FDG PET/CT scan between RT fractions 5-6 (before course 2 of chemotherapy). Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection. |
进行 FDG PET/CT
其他名称：
Undergo FDG PET/CT
|
|
实验性的：Group B (FDG PET/CT between RT fractions 10-11)
Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy. Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of chemotherapy). Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection. |
进行 FDG PET/CT
其他名称：
Undergo FDG PET/CT
|
|
实验性的：Group C (FDG PET/CT between RT fractions 15-16)
Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy. Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of chemotherapy). Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection. |
进行 FDG PET/CT
其他名称：
Undergo FDG PET/CT
|
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 |
|---|---|---|
|
Induction therapy failure
大体时间：6 weeks after completion of chemoradiation therapy (CRT)
|
Defined as any evidence by clinically unresectable disease based on tumor board consensus and review of restaging scans demonstrating locoregional progression or distant metastasis, surgically unresectable disease based on surgical exploration, or suboptimal resection disease still requiring pneumonectomy and still having R1 resection.
|
6 weeks after completion of chemoradiation therapy (CRT)
|
|
Early positron emission tomography (PET) response of group A
大体时间：Baseline and between standard radiotherapy (RT) fractions 5-6
|
Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
|
Baseline and between standard radiotherapy (RT) fractions 5-6
|
|
Early positron emission tomography (PET) response of group B
大体时间：Baseline and between standard radiotherapy (RT) fractions 10-11
|
Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
|
Baseline and between standard radiotherapy (RT) fractions 10-11
|
|
Early positron emission tomography (PET) response of group C
大体时间：Baseline and between standard radiotherapy (RT) fractions 15-16
|
Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
|
Baseline and between standard radiotherapy (RT) fractions 15-16
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Pathologic response
大体时间：6 weeks after completion of chemoradiation therapy (CRT)
|
6 weeks after completion of chemoradiation therapy (CRT)
|
|
Progression-free survival
大体时间：Every 3 months for 2 years and every 6 months thereafter
|
Every 3 months for 2 years and every 6 months thereafter
|
|
Overall survival
大体时间：Every 3 months for 2 years and every 6 months thereafter
|
Every 3 months for 2 years and every 6 months thereafter
|
合作者和调查者
调查人员
- 首席研究员：Khanh Nguyen、City of Hope Medical Center
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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