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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


Phase 3
20 Years
75 Years
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:

No

Principal Investigator

Mamoru Tsukuda, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Yokohama City University

Authority:

United States: Federal Government

Study ID:

YCU-BRI-HN-05-01

NCT ID:

NCT00336947

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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