336947
Last Update Posted: 2013-05-15
Recruiting status is unknown
All Genders accepted | 20 Years-75 Years |
500 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
S-1 or Tegafur-Uracil in Treating Patients With Previously Treated Stage III or Stage IV Head and Neck Cancer
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.
Eligibility
Relevant conditions:
Head and Neck Cancer
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
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Data sourced from ClinicalTrials.gov