A Phase ll Trial of Induction Docetaxel and S-1 Followed by Concomitant Radiotherapy With Low-dose Daily Cisplatin in Locally Advanced Head and Neck Cancer
- To assess the response rate in patients with stage III or IV head and neck cancer
treated with induction therapy comprising docetaxel and S-1 followed by radiotherapy
and low-dose cisplatin.
- To assess the effect of this regimen on survival and locoregional and systemic control
rates in these patients.
- Induction chemotherapy: Patients receive oral S-1 twice daily on days 1-14 and
docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses in the
absence of disease progression or unacceptable toxicity.
- Chemoradiotherapy: Patients receive low-dose cisplatin IV once daily and undergo
radiotherapy 5 days a week for 7 weeks in the absence of disease progression or
After completion of study therapy, patients are followed periodically for 18 months.
Masking: Open Label, Primary Purpose: Treatment
Objective response rate (complete or partial response) as assessed by RECIST criteria
Joo-Hang Kim, MD