A Phase II Trial of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer
Many studies have shown the superiority of concurrent chemoradiotherapy over radiotherapy
only in locally advanced head and neck cancer. Concurrent chemoradiotherapy with high dose
cisplatin has been universally used regimen. In a large-scaled phase II trial, however,
conducted by the European Organization for the Research and Treatment of Cancer (EORTC),
docetaxel (100mg/m2) plus cisplatin (75mg/ m2) every three weeks regimen produced improved
survival, nonetheless there was significant limitation to deliver full doses of treatment
due to significant hematologic and non-hematologic toxicities. Previously, we showed the
safety of the combination regimen of weekly docetaxel and cisplatin in concurrent
chemoradiation treatment in a phase I study. We determined the MTD of docetaxel to be
20mg/m2 weekly when concurrently administered with conventional fractionation RT and weekly
20mg/m2 of cisplatin.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate
3-4 weeks after completion of CCRT
No
Korea: Food and Drug Administration
2009-10-007
NCT01126008
December 2009
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