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

Yokohama City University500 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

500

Conditions

Head and Neck Cancer

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (48)

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Fujita Health University

Toyoake, Aichi-ken, Japan

Akita University Hospital

Akita, Akita, Japan

Tokyo Dental College Ichikawa General Hospital

Ichikawa, Chiba, Japan

Ehime University Hospital

Tōon, Ehime, Japan

University of Fukui Hospital

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

Overview

Conditions

Interventions

Eligibility

Locations (48)

Outcomes

Primary Outcomes

Secondary Outcomes