Elderly NSCLC/D vs DP (JCOG0207)
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|ClinicalTrials.gov Identifier: NCT00190476|
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : September 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-small-cell Lung Cancer||Drug: Weekly docetaxel alone Drug: Weekly docetaxel + cisplatin combination||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)|
|Study Start Date :||April 2003|
|Study Completion Date :||April 2007|
- overall survival
- Progression-free survival
- Response rate
- Symptom score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190476
|Study Chair:||Akira Yokoyama, MD, PhD||Department of Internal Medicine, Niigata Cancer Center Hospital|