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Sponsored by: |
Yokohama City University Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00336947 |
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 |
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Head and Neck Cancer |
Drug: S-1 Drug: tegafur-uracil Procedure: adjuvant therapy |
Phase III |
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 |
Estimated Enrollment: | 500 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)
Completed definitive treatment for SCCHN within the past 3 months, that included any of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Japan | |
University of Fukui Hospital | |
Fukui, Japan, 910-1193 | |
Fukushima Medical University Hospital | |
Fukushima, Japan, 960-1295 | |
Kagoshima University | |
Kagoshima, Japan, 890-8520 | |
Osaka City University | |
Osaka, Japan, 558-8585 | |
Osaka General Medical Center | |
Osaka, Japan, 558-0056 | |
Saitama Cancer Center | |
Saitama, Japan, 362-0806 | |
Tokyo Medical and Dental University | |
Tokyo, Japan, 113-8510 | |
International Medical Center of Japan | |
Tokyo, Japan, 162-8655 | |
Juntendo University School of Medicine | |
Tokyo, Japan, 113-8421 | |
Keio University School of Medicine | |
Tokyo, Japan, 160-8582 | |
Nippon Medical School | |
Tokyo, Japan, 113 | |
Cancer Institute Hospital of Japanese Foundation for Cancer Research | |
Tokyo, Japan, 135-8550 | |
Tokyo Medical University | |
Tokyo, Japan, 160-0023 | |
Japan, Aichi | |
Aichi Cancer Center | |
Nagoya, Aichi, Japan, 464-8681 | |
Fujita Health University | |
Toyoake, Aichi, Japan, 470-11 | |
Japan, Akita | |
Akita University Hospital | |
Akita City, Akita, Japan, 010-854 | |
Japan, Chiba | |
Tokyo Dental College Ichikawa General Hospital | |
Ichikawa, Chiba, Japan, 272-8513 | |
Japan, Ehime | |
Ehime University Hospital | |
Toon, Ehime, Japan, 791-0295 | |
Japan, Fukuoka | |
National Kyushu Cancer Center | |
Fukuoka-shi, Fukuoka, Japan, 811-1395 | |
Japan, Gifu | |
Gifu University Graduate School of Medicine | |
Gifu-shi, Gifu, Japan, 501-1194 | |
Japan, Gunma | |
Gunma University Graduate School of Medicine | |
Maebashi, Gunma, Japan, 371-8511 | |
Japan, Hokkaido | |
Hokkaido University Hospital | |
Sapporo, Hokkaido, Japan, 060-8637 | |
Japan, Hyogo | |
Hyogo Cancer Center | |
Akashi City, Hyogo, Japan, 673-8558 | |
National Hospital Organization - Himeji Medical Center | |
Himeji-shi, Hyogo, Japan, 650-0017 | |
Japan, Ishikawa | |
Kanazawa Medical University | |
Kanazawa, Ishikawa, Japan, 920-0934 | |
Japan, Iwate | |
Iwate Medical University Hospital | |
Morioka-shi, Iwate, Japan, 020-8505 | |
Japan, Kagoshima | |
Kagoshima City Hospital | |
Kagoshima City, Kagoshima, Japan, 892-8580 | |
Japan, Kanagawa | |
Yokohama City University | |
Yokohama, Kanagawa, Japan, 232-0024 | |
Yokohama Rosai Hospital | |
Yokohama, Kanagawa, Japan, 222-0036 | |
Japan, Kumamoto | |
Kumamoto University Medical School | |
Kumamoto City, Kumamoto, Japan, 860-8556 | |
Japan, Mie | |
Mie University Graduate School of Medicine | |
Tsu, Mie, Japan, 514 | |
Japan, Miyagi | |
Tohoku University Graduate School of Medicine | |
Sendai, Miyagi, Japan, 980-8574 | |
Japan, Miyazaki | |
Miyazaki Medical College University of Miyazaki | |
Miyazaki-gun, Miyazaki, Japan, 889-1692 | |
Japan, Nara | |
Tenri Hospital | |
Tenri, Nara, Japan, 632-8552 | |
Japan, Niigata | |
Niigata Prefectural Central Hospital | |
Joetsu, Niigata, Japan, 943-0192 | |
Japan, Okayama | |
Kawasaki Medical School | |
Kurashiki, Okayama, Japan, 701-01 | |
Japan, Osaka | |
Kinki University School of Medicine | |
Osakasayama, Osaka, Japan, 589-8511 | |
Japan, Shimane | |
Shimane University Hospital | |
Izumo, Shimane, Japan, 693-8501 | |
Japan, Shizuoka | |
Hamamatsu University School of Medicine | |
Hamamatsu, Shizuoka, Japan, 431-31 | |
Seirei Hamamatsu General Hospital | |
Hamamatsu, Shizuoka, Japan, 430-8558 | |
Japan, Tochigi | |
Saiseikai Utsunomiya Hospital | |
Utsunomiya, Tochigi, Japan, 321-0974 | |
Japan, Tokyo | |
Kyorin University School of Medicine - Mitaka Campus | |
Mitaka-shi, Tokyo, Japan, 181-8611 | |
National Tokyo Medical Center | |
Menguro-ku, Tokyo, Japan, 152-8902 | |
Ome Municipal General Hospital | |
Ome-shi, Tokyo, Japan, 198-0042 | |
Tokyo Medical University Hachioji Medical Center | |
Hachioji, Tokyo, Japan, 193-0998 | |
Japan, Tottori | |
Tottori University Hospital | |
Yonago-shi, Tottori, Japan, 683-8504 | |
Japan, Wakayama | |
Wakayama Medical University | |
Wakayama-shi, Wakayama, Japan, 641-8510 | |
Japan, Yamagata | |
Interdiciplinary Graduate School of Medicine and Engineering | |
Yamanashi, Yamagata, Japan, 409-3898 |
Study Chair: | Mamoru Tsukuda, MD | Yokohama City University Medical Center |
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 |
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 |
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 |
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 |