Randomized Controlled Trial Comparing Docetaxel-Cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-Small-Cell Lung Cancer(JCOG0207)
The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the
utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer
(NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any
advantage over either agent alone. With the current evidence, single agent chemotherapy with
a third-generation drug can be considered a recommended option for elderly patients with
advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%,
median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in
patients older than age 75 years. There have been no randomized prospective trials dedicated
to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based
combination.
Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin
combination for elderly advanced NSCLC.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
Akira Yokoyama, MD, PhD
Study Chair
Department of Internal Medicine, Niigata Cancer Center Hospital
Japan: Ministry of Health, Labor and Welfare
JCOG0207
NCT00190476
April 2003
April 2007
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