This trial is active, not recruiting.

Condition head and neck cancer
Treatments tegafur-gimeracil-oteracil potassium, tegafur-uracil, adjuvant therapy
Phase phase 3
Sponsor Yokohama City University
Start date April 2006
End date March 2012
Trial size 500 participants
Trial identifier NCT00336947, CDR0000486874, YCU-BRI-HN-05-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Disease-free survival
time frame:

Secondary Outcomes

Relapse-free survival
time frame:
Overall survival
time frame:
Adverse effects
time frame:

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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

Additional 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).