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
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
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
GROUP B: Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of
GROUP C: Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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)
City of Hope Medical Center
United States: Institutional Review Board