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Last Modified: 9/11/2008     First Published: 6/9/2006  
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Phase III Randomized Study of Adjuvant Chemotherapy Comprising S-1 Versus Tegafur-Uracil (UFT) in Patients With Definitively Treated Stage III or IV Squamous Cell Carcinoma of the Head and Neck

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed20 to 75OtherYCU-BRI-HN-05-01
NCT00336947

Objectives

  1. 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).

Entry 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


Prior/Concurrent Therapy:

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

Patient Characteristics:

  • ECOG performance status 0-1
  • WBC ≥ 3,500/mm3 AND ≤ 12,000/mm3
  • Neutrophil count ≥ 2,000/mm3
  • Platelet count ≥ 100,000/mm3
  • 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

Expected Enrollment

500

A total of 500 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Disease-free survival

Secondary Outcome(s)

Relapse-free survival
Overall survival
Adverse effects

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.


Trial Contact Information

Trial Lead Organizations

Yokohama City University

Mamoru Tsukuda, MD, Protocol chair
Ph: 81-45-787-2685
Email: mtsukuda@med.yokohama-cu.ac.jp

Registry 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
Trial Start Date 2006-04-01
Trial Completion Date 2012-03-31 (estimated)
Registered in ClinicalTrials.gov NCT00336947
Date Submitted to PDQ 2006-04-18
Information Last Verified 2008-12-28

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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