Stage IIIA Non-small Cell Lung Cancer
Conditions
Brief summary
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
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.
Interventions
Undergo FDG PET/CT
RADIATIONfludeoxyglucose F 18
Undergo FDG PET/CT
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Induction therapy failure | 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 | 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 | 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 | 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. |
Secondary
| Measure | 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 |
Outcome results
None listed