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

Sponsored by:	Yokohama City University Medical Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00336947

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: S-1 Drug: tegafur-uracil Procedure: adjuvant therapy	Phase III

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Uracil Tegafur S 1 (Combination)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relapse-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Adverse effects [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	April 2006
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336947

Show 48 Study Locations

Sponsors and Collaborators

Yokohama City University Medical Center

Investigators

Study Chair:

Mamoru Tsukuda, MD

Yokohama City University Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000486874, YCU-BRI-HN-05-01
Study First Received:	June 13, 2006
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00336947 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Antimetabolites
Laryngeal Carcinoma
Tegafur
Carcinoma, Squamous Cell of Head and Neck
Adjuvants, Immunologic
Squamous Cell Carcinoma
Carcinoma

Hypopharyngeal Cancer
Head and Neck Neoplasms
Epidermoid Carcinoma
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Tegafur
Pharmacologic Actions
Carcinoma

Neoplasms
Neoplasms by Site
Therapeutic Uses
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009