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


Yokohama City University

Status and phase

Phase 3


Head and Neck Cancer


Drug: tegafur-uracil
Drug: tegafur-gimeracil-oteracil potassium
Procedure: adjuvant therapy

Study type


Funder types



CDR0000486874 (Registry Identifier)

Details and patient eligibility


RATIONALE: Drugs used in chemotherapy, such as S-1 and tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving S-1 or tegafur-uracil after surgery, chemotherapy, biological therapy, and/or radiation therapy may kill any remaining tumor cells. It is not yet known whether S-1 is more effective than tegafur-uracil in treating head and neck cancer. PURPOSE: This randomized phase III trial is studying S-1 to see how well it works compared with tegafur-uracil in treating patients with previously treated stage III or stage IV head and neck cancer.

Full description

OBJECTIVES: 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). 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. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.


500 estimated patients




20 to 75 years old


No Healthy Volunteers

Inclusion and exclusion criteria


  • 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


  • ECOG performance status 0-1
  • WBC ≥ 3,500/mm^3 AND ≤ 12,000/mm^3
  • Neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • 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


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

Trial contacts and locations



Data sourced from clinicaltrials.gov

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