Fludeoxyglucose F 18 PET/CT Scans in Predicting Therapy Response in Patients With Stage IIIA Non-Small Cell Lung Cancer Undergoing Chemoradiation

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Stage IIIA Non-small Cell Lung Cancer

Intervention / Treatment
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* Procedure: positron emission tomography/computed tomography (PET/CT)
* Radiation: fludeoxyglucose F 18


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (FDG PET/CT between RT fractions 5-6)<br>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. | Procedure: positron emission tomography/computed tomography (PET/CT)<br>* Undergo FDG PET/CT<br>Radiation: fludeoxyglucose F 18<br>* Undergo FDG PET/CT<br>* Other names: FDG;|
| Experimental: Group B (FDG PET/CT between RT fractions 10-11)<br>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. | Procedure: positron emission tomography/computed tomography (PET/CT)<br>* Undergo FDG PET/CT<br>Radiation: fludeoxyglucose F 18<br>* Undergo FDG PET/CT<br>* Other names: FDG;|
| Experimental: Group C (FDG PET/CT between RT fractions 15-16)<br>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. | Procedure: positron emission tomography/computed tomography (PET/CT)<br>* Undergo FDG PET/CT<br>Radiation: fludeoxyglucose F 18<br>* Undergo FDG PET/CT<br>* Other names: FDG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction therapy failure | 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 | 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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |