Trial Comparing the Use of FLT PET to Standard CT to Assess Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable NSCLC

• Change in FLT uptake (measured in quantitative SUVs and Ki) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  Will be calculated by subtracting the uptake of the scan after the first cycle of chemotherapy from the uptake of the pre-treatment scan.
  
  
• Change in FLT uptake [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  Will be utilized as a continuous variable.
  
  
• Change in FLT uptake in responders and non-responders [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  Unadjusted analysis will be performed utilizing students t-tests. If the data appears non-normal, the Wilcox on rank-sum test will be used rather than the t-test. Adjusted analysis will be performed utilizing logistic regression.
  
  

• Change in FLT uptake comparing the scan after the second cycle of chemotherapy with the uptake of the pre-treatment scan [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  Will be calculated by subtracting the uptake of the scan after the second cycle of chemotherapy from the uptake of the pre-treatment scan.
  
  
• Change in FDG uptake comparing the scans after both the first and second cycles of chemotherapy with the uptake of the pre-treatment scan [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  Will be calculated by subtracting the uptake of the scan after the first and second cycles of chemotherapy from the uptake of the pre-treatment scan.
  
  
• Overall response rate reported as a proportion of the total number of patients who received at least one cycle of therapy assessed using RECIST criteria [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
  

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.