Phase II Single-Arm Trial Comparing the Use of FLT PET to Standard Computed Tomography to Assess the Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable Non-Small Cell Lung Cancer
I. To determine if the absolute decrease measured in primary tumor 18
F-F-3'-fluoro-3'-deoxy-L-thymidine (FLT) uptake (standard uptake value [SUV] and influx
constant [Ki]) between pre-treatment imaging and imaging after the first cycle of therapy
differs in patients categorized as responders or non-responders based on Response Evaluation
Criteria in Solid Tumors (RECIST) measured with computed tomography (CT) after the second
cycle of therapy.
I. To determine if the absolute decrease measured in primary tumor FDG uptake (SUV) between
pre-treatment imaging and imaging after the first cycle of therapy differs in patients
categorized as responders or non-responders based on RECIST measured with CT after the
second cycle of therapy.
II. To assess the effects of the combination of docetaxel and cisplatin on fractional tumor
viability and proliferative fraction pre and post treatment and to correlate these with the
PET SUV data for both tracers.
III. To assess the methylation status of the checkpoint with forkhead and ring finger
domains gene (CHFR) gene from pre-treatment tumor biopsies and correlate methylation status
post treatment with clinical and pathologic response.
Patients receive docetaxel intravenously (IV) and cisplatin IV on day 1 and dexamethasone
orally (PO) twice daily (BID). Treatment repeats every 3 weeks for 2 courses in the absence
of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT,
and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.
After completion of study treatment, patients are followed up for 4-6 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Change in FLT uptake (measured in quantitative SUVs and Ki)
Will be calculated by subtracting the uptake of the scan after the first cycle of chemotherapy from the uptake of the pre-treatment scan.
Baseline and 6 weeks
Johns Hopkins University
United States: Food and Drug Administration
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