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

Y

Yokohama City University

Status and phase

Unknown
Phase 3

Conditions

Head and Neck Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00336947
YCU-BRI-HN-05-01
CDR0000486874 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

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

Trial contacts and locations

48

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Data sourced from clinicaltrials.gov

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