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

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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