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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yokohama City University
• Treatments: Tegafur

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