Lung Cancer Clinical Trial
Official title:
The Role of PET During Erlotinib Treatment to See the Responsiveness of Tumor Early in Patients With Non-small Cell Lung Cancer
Erlotinib is an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.
Higher response rates were observed in a subset of patients with female gender, Asian
ethnicity, no smoking history, mutations in EGFR tyrosine kinase, high EGFR gene copy number
and adenocarcinoma histology. However, the therapeutic effect of Erlotinib is not confined
to patients whose tumors harbor EGFR mutations and other predictors of efficacy of this
agent. And these tests require time and sufficiently large specimens for processing, whereas
many patients with advanced NSCLC are diagnosed based on cytology alone.
This study was designed to evaluate FLT-PET or FDG-PET usefulness in the early assessment of
treatment response and in predicting patient outcome after erlotinib monotherapy for
patients with non-small cell lung cancer prospectively. Changes in tumor FLT or FDG uptake 7
days after the initiation of treatment will be compared between responders and nonresponders
based on subsequent CT scans.
1. Primary objectives:
To see whether the % change in SUVmax of a tumor with FLT-PET or FDG-PET at 7 days
after initiating erlotinib treatment compared with baseline SUVmax (ΔSUVmax) would
predict the tumor's responsiveness. And the responsiveness will be decided with the CT
scan after 6 weeks of erlotinib treatment.
2. Secondary objectives:
To compare ΔSUVmax and the degree of tumor shrinkage in longest diameter during erlotinib
treatment.
To see ΔSUVmax in the tumors with stable disease. To see the time to progression and overall
survival according to ΔSUVmax. To compare the result of FDG-PET and FLT-PET.
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Observational Model: Cohort, Time Perspective: Prospective
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