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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Induction therapy failure
研究概览
简要总结
This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/computed tomography (CT) in predicting chemoradiation therapy (CRT) failure in patients with stage IIIA non-small cell lung cancer (NSCLC). Diagnostic procedures, such as FDG PET/CT, may help predict CRT failure. Comparing diagnostic results during CRT may help doctors predict a patient's response to treatment and help plan the best treatment
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Induction therapy failure
时间窗: 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.
Early positron emission tomography (PET) response of group A
时间窗: 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.
Early positron emission tomography (PET) response of group B
时间窗: 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.
Early positron emission tomography (PET) response of group C
时间窗: 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.
次要结局
- Pathologic response(6 weeks after completion of chemoradiation therapy (CRT))
- Progression-free survival(Every 3 months for 2 years and every 6 months thereafter)
- Overall survival(Every 3 months for 2 years and every 6 months thereafter)