Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Phase 2

• Conditions: Head and Neck Cancer

• Registration Number: NCT00625937
• Lead Sponsor: Yonsei University

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, S-1, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and S-1 together with radiation therapy and low-dose cisplatin works in treating patients with stage III or stage IV head and neck cancer.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* To assess the effect of this regimen on survival and locoregional and systemic control rates in these patients.

OUTLINE:

* 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 unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 18 months.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-02-29
• Primary Completion: 2010-11
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-25
• Last Update Posted: 2011-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate (complete or partial response) as assessed by RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Toxicity as assessed by NCI CTCAE v3.0 criteria
Overall survival
Progression-free survival

Trial Locations

Locations (1)

Yonsei Cancer Center at Yonsei University Medical Center; 🇰🇷 Seoul, Korea, Republic of