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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00336947
• Other study ID #: YCU-BRI-HN-05-01
• Secondary ID: CDR0000486874
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 13, 2006
• Last updated: May 14, 2013
• Start date: April 2006

Study information

• Verified date: December 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• tegafur-gimeracil-oteracil potassium

• tegafur-uracil

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
Japan	Hyogo Cancer Center	Akashi City	Hyogo
Japan	Akita University Hospital	Akita City	Akita
Japan	University of Fukui Hospital	Fukui
Japan	National Kyushu Cancer Center	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Gifu University Graduate School of Medicine	Gifu-shi	Gifu
Japan	Tokyo Medical University Hachioji Medical Center	Hachioji	Tokyo
Japan	Hamamatsu University School of Medicine	Hamamatsu	Shizuoka
Japan	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka
Japan	National Hospital Organization - Himeji Medical Center	Himeji-shi	Hyogo
Japan	Tokyo Dental College Ichikawa General Hospital	Ichikawa	Chiba
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Niigata Prefectural Central Hospital	Joetsu	Niigata
Japan	Kagoshima University	Kagoshima
Japan	Kagoshima City Hospital	Kagoshima City	Kagoshima
Japan	Kanazawa Medical University	Kanazawa	Ishikawa
Japan	Kumamoto University Medical School	Kumamoto City	Kumamoto
Japan	Kawasaki Medical School	Kurashiki	Okayama
Japan	Gunma University Graduate School of Medicine	Maebashi	Gunma
Japan	National Tokyo Medical Center	Menguro-ku	Tokyo
Japan	Kyorin University School of Medicine - Mitaka Campus	Mitaka-shi	Tokyo
Japan	Miyazaki Medical College University of Miyazaki	Miyazaki-gun	Miyazaki
Japan	Iwate Medical University Hospital	Morioka-shi	Iwate
Japan	Aichi Cancer Center	Nagoya	Aichi
Japan	Ome Municipal General Hospital	Ome-shi	Tokyo
Japan	Osaka City University	Osaka
Japan	Osaka General Medical Center	Osaka
Japan	Kinki University School of Medicine	Osakasayama	Osaka
Japan	Saitama Cancer Center	Saitama
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Tohoku University Graduate School of Medicine	Sendai	Miyagi
Japan	Tenri Hospital	Tenri	Nara
Japan	Cancer Institute Hospital of Japanese Foundation for Cancer Research	Tokyo
Japan	International Medical Center of Japan	Tokyo
Japan	Juntendo University School of Medicine	Tokyo
Japan	Keio University School of Medicine	Tokyo
Japan	Nippon Medical School	Tokyo
Japan	Tokyo Medical and Dental University	Tokyo
Japan	Tokyo Medical University	Tokyo
Japan	Ehime University Hospital	Toon	Ehime
Japan	Fujita Health University	Toyoake	Aichi
Japan	Mie University Graduate School of Medicine	Tsu	Mie
Japan	Saiseikai Utsunomiya Hospital	Utsunomiya	Tochigi
Japan	Wakayama Medical University	Wakayama-shi	Wakayama
Japan	Interdiciplinary Graduate School of Medicine and Engineering	Yamanashi	Yamagata
Japan	Yokohama City University	Yokohama	Kanagawa
Japan	Yokohama Rosai Hospital	Yokohama	Kanagawa
Japan	Tottori University Hospital	Yonago-shi	Tottori

Sponsors (1)

Lead Sponsor	Collaborator
Yokohama City University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival			No
Secondary	Relapse-free survival			No
Secondary	Overall survival			No
Secondary	Adverse effects			Yes