NCT00190476

Elderly NSCLC/D vs DP (JCOG0207)

Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (planned)
• Sponsor: Japan Clinical Oncology Group · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.

Detailed description

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.

Conditions

• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Weekly docetaxel alone
DRUG	Weekly docetaxel + cisplatin combination

Timeline

• Start date: 2003-04-01
• Completion: 2007-04-01
• First posted: 2005-09-19
• Last updated: 2016-09-12

Locations

29 sites across 1 country: Japan