Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

S-1 or Tegafur-Uracil in Treating Patients With Previously Treated Stage III or Stage IV Head and Neck Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	20 to 75	Other	YCU-BRI-HN-05-01 NCT00336947

Objectives

1. Compare the disease-free survival rate in patients with definitively treated stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemotherapy comprising S-1 vs tegafur-uracil (UFT).

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)
  • Stage III or IV disease
  • Primary tumor in the mesopharynx, hypopharynx, larynx (except T3 N0 tumors of the glottis), oral cavity, or maxillary sinus



• Completed definitive treatment for SCCHN within the past 3 months, that included any of the following:
  • Surgery
  • Chemotherapy
  • Biologic therapy
  • Radiotherapy (e.g., radiotherapy in combination with chemotherapy or pre- or postoperative radiotherapy)
  • Any other treatment



• No clinical evidence of locoregional tumors or distant metastasis within 3 months after the completion of definitive treatment

Prior/Concurrent Therapy:

• See Disease Characteristics
• No concurrent biologic therapy, radiotherapy, other chemotherapy, or any other therapy

Patient Characteristics:

• ECOG performance status 0-1
• WBC ≥ 3,500/mm³ AND ≤ 12,000/mm³
• Neutrophil count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• AST and ALT < 100 IU/L
• Bilirubin < 1.5 mg/dL
• Creatinine < 1.2 mg/dL
• No uncontrolled cardiovascular disease
• No interstitial pneumonia or pulmonary fibrosis
• Must have sufficient oral intake

Expected Enrollment

A total of 500 patients will be accrued for this study.

Outcomes

Disease-free survival

Relapse-free survival
Overall survival
Adverse effects

Outline

This is a randomized, controlled, multicenter study. Patients are stratified according to primary site, disease stage, type of prior definitive treatment, and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral S-1 once daily on days 1-14. Courses repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity.



• Arm II:Patients receive oral tegafur-uracil (UFT) once daily on days 1-21. Courses repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity.

Trial Contact Information

Trial Lead Organizations

Yokohama City University

Mamoru Tsukuda, MD, Protocol chair		Ph: 81-45-787-2685 Email: mtsukuda@med.yokohama-cu.ac.jp

Registry Information
Official Title		Controlled Randomized Trial to Evaluate Efficacy of Adjuvant Chemotherapy between S-1 and UFT for Locally Advanced Squamous Cell Carcinoma of the Head and Neck: Phase III Study
Trial Start Date		2006-04-01
Trial Completion Date		2012-03-31 (estimated)
Registered in ClinicalTrials.gov		NCT00336947
Date Submitted to PDQ		2006-04-18
Information Last Verified		2008-12-28

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