Non-Small Cell Lung Cancer Clinical Trial
Official title:
Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly
gemcitabine in elder patients (> 75) with previously untreated advanced non-small cell lung
cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST
criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly
single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (>
76 years) who have received no prior treatment for non-small lung cancer. As secondary
objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin
combination chemotherapy, progression-free survival and overall survival will be evaluated
in both patients with biweekly gemcitabine and carboplatin combination chemotherapy and
weekly single gemcitabine.
The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus
carboplatin may improve the efficacy.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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