Spots Global Cancer Trial Database for S-1 or Tegafur-Uracil in Treating Patients With Previously Treated Stage III or Stage IV Head and Neck Cancer
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Trial Identification
Brief Title: S-1 or Tegafur-Uracil in Treating Patients With Previously Treated Stage III or Stage IV Head and Neck Cancer
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
Study ID: NCT00336947
Conditions
Study Description
Brief 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.
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.
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aichi Cancer Center, Nagoya, Aichi, Japan
Fujita Health University, Toyoake, Aichi, Japan
Akita University Hospital, Akita City, Akita, Japan
Tokyo Dental College Ichikawa General Hospital, Ichikawa, Chiba, Japan
Ehime University Hospital, Toon, Ehime, Japan
National Kyushu Cancer Center, Fukuoka-shi, Fukuoka, Japan
Gifu University Graduate School of Medicine, Gifu-shi, Gifu, Japan
Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Hyogo Cancer Center, Akashi City, Hyogo, Japan
National Hospital Organization - Himeji Medical Center, Himeji-shi, Hyogo, Japan
Kanazawa Medical University, Kanazawa, Ishikawa, Japan
Iwate Medical University Hospital, Morioka-shi, Iwate, Japan
Kagoshima City Hospital, Kagoshima City, Kagoshima, Japan
Yokohama Rosai Hospital, Yokohama, Kanagawa, Japan
Yokohama City University, Yokohama, Kanagawa, Japan
Kumamoto University Medical School, Kumamoto City, Kumamoto, Japan
Mie University Graduate School of Medicine, Tsu, Mie, Japan
Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan
Miyazaki Medical College University of Miyazaki, Miyazaki-gun, Miyazaki, Japan
Tenri Hospital, Tenri, Nara, Japan
Niigata Prefectural Central Hospital, Joetsu, Niigata, Japan
Kawasaki Medical School, Kurashiki, Okayama, Japan
Kinki University School of Medicine, Osakasayama, Osaka, Japan
Shimane University Hospital, Izumo, Shimane, Japan
Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan
Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan
Saiseikai Utsunomiya Hospital, Utsunomiya, Tochigi, Japan
Tokyo Medical University Hachioji Medical Center, Hachioji, Tokyo, Japan
National Tokyo Medical Center, Menguro-ku, Tokyo, Japan
Kyorin University School of Medicine - Mitaka Campus, Mitaka-shi, Tokyo, Japan
Ome Municipal General Hospital, Ome-shi, Tokyo, Japan
Tottori University Hospital, Yonago-shi, Tottori, Japan
Wakayama Medical University, Wakayama-shi, Wakayama, Japan
Interdiciplinary Graduate School of Medicine and Engineering, Yamanashi, Yamagata, Japan
University of Fukui Hospital, Fukui, , Japan
Fukushima Medical University Hospital, Fukushima, , Japan
Kagoshima University, Kagoshima, , Japan
Osaka General Medical Center, Osaka, , Japan
Osaka City University, Osaka, , Japan
Saitama Cancer Center, Saitama, , Japan
Juntendo University School of Medicine, Tokyo, , Japan
Tokyo Medical and Dental University, Tokyo, , Japan
Nippon Medical School, Tokyo, , Japan
Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, , Japan
Tokyo Medical University, Tokyo, , Japan
Keio University School of Medicine, Tokyo, , Japan
International Medical Center of Japan, Tokyo, , Japan
Contact Details
Name: Mamoru Tsukuda, MD
Affiliation: Yokohama City University
Role: STUDY_CHAIR
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