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

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Exclusion Criteria

Not provided

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

Trial Locations

Locations (1)

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