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Last Modified: 10/23/2007     First Published: 6/9/2006  
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Phase III Randomized Study of Adjuvant Chemotherapy Comprising S-1 Versus Tegafur-Uracil (UFT) in Patients With Definitively Treated Stage III or IV Squamous Cell Carcinoma of the Head and Neck

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III


Treatment


Active


20 to 75


Other


YCU-BRI-HN-05-01
NCT00336947

Objectives

  1. 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).

Entry 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


Prior/Concurrent Therapy:

  • See Disease Characteristics
  • No concurrent biologic therapy, radiotherapy, other chemotherapy, or any other therapy

Patient Characteristics:

  • ECOG performance status 0-1
  • WBC ≥ 3,500/mm3 AND ≤ 12,000/mm3
  • Neutrophil count ≥ 2,000/mm3
  • Platelet count ≥ 100,000/mm3
  • 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

Expected Enrollment

500

A total of 500 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Disease-free survival

Secondary Outcome(s)

Relapse-free survival
Overall survival
Adverse effects

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.


Trial Contact Information

Trial Lead Organizations

Yokohama City University

Mamoru Tsukuda, MD, Protocol chair
Ph: 81-45-787-2685
Email: mtsukuda@med.yokohama-cu.ac.jp

Trial Sites

Japan
Aichi
  Nagoya
 Aichi Cancer Center
 Yasuhisa Hasegawa, MD
Ph: 81-52-762-6111
 Email: hasegawa@aichi-cc.jp
  Toyoake
 Fujita Health University
 Kazuo Sakurai, MD
Ph: 81-562-93-9291
Akita
  Akita City
 Akita University Hospital
 Shinsuke Suzuki, MD
Ph: 81-18-884-6171
 Email: shinsuke@med.akita-u.ac.jp
Chiba
  Ichikawa
 Tokyo Dental College Ichikawa General Hospital
 Yuichiro Okazaki, MD
Ph: 81-47-322-0151
Ehime
  Toon
 Ehime University Hospital
 Masamitsu Hyodo, MD
Ph: 81-89-960-5366
 Email: hyodoma@m.ehime-u.ac.jp
Fukui
  Fukui
 University of Fukui Hospital
 Hideaki Tsuzuki, MD
Ph: 81-776-61-8407
 Email: hideaki@fmsrsa.fukui-med.ac.jp
Fukuoka
  Fukuoka-shi
 National Kyushu Cancer Center
 Kichinobu Tomita, MD
Ph: 81-92-541-3231
 Email: kctomita@nk-cc.go.jp
Fukushima
  Fukushima
 Fukushima Medical University Hospital
 Takashi Matsuzuka, MD
Ph: 81-24-548-2111
 Email: tmtzk@fmu.ac.jp
Gifu
  Gifu-shi
 Gifu University Graduate School of Medicine
 Keisuke Mizuta, MD
Ph: 81-58-230-6279
 Email: kmizuta@cc.gifu-u.ac.jp
Gunma
  Maebashi
 Gunma University Graduate School of Medicine
 Kazuaki Chikamatsu, MD
Ph: 81-27-220-8365
 Email: tikamatu@med.gunma-u.ac.jp
Hokkaido
  Sapporo
 Hokkaido University Hospital
 Akihiro Homma, MD
Ph: 81-11-716-1161 ext. 5959
 Email: ak-homma@med.hokudai.ac.jp
Hyogo
  Akashi City
 Hyogo Cancer Center
 Shigemichi Iwae, MD
Ph: 81-78-929-1151
 Email: s.iwae@hp.pref.hyogo.jp
  Himeji-shi
 National Hospital Organization - Himeji Medical Center
 Masaki Uozumi, MD
Ph: 81-792-25-3211
Ishikawa
  Kanazawa
 Kanazawa Medical University
 Naohiro Wakisaka, MD
Ph: 81-76-265-2413
 Email: wakisaka@med.kanazawa-u.ac.jp
Iwate
  Morioka-shi
 Iwate Medical University Hospital
 Yoshihiro Kamada, MD
Ph: 81-19-651-5110
Kagoshima
  Kagoshima
 Kagoshima University
 Tatsuya Fukuiwa, MD
Ph: 81-99-275-5410
 Email: silvian@m2.kufm.kagoshima-u.ac.jp
  Kagoshima City
 Kagoshima City Hospital
 Yutaka Hanamure, MD
Ph: 81-99-224-2101
 Email: hanam@ml.kch.kagoshima.kagoshima.jp
Kanagawa
  Yokohama
 Yokohama City University
 Junichi Ishitoya, MD
Ph: 81-45-261-5656
 Email: ishitoya@med.yokohama-cu.ac.jp
 Yokohama Rosai Hospital
 Hideki Takemura, MD
Ph: 81-45-474-8111
Kumamoto
  Kumamoto City
 Kumamoto University Medical School
 Ryosei Minoda, MD, PhD
Ph: 81-96-344-2111
Mie
  Tsu
 Mie University Graduate School of Medicine
 Shinobu Arima, MD
Ph: 81-59-232-1111
 Email: shiouma@mbj.nifty.com
Miyazaki
  Miyazaki-gun
 Miyazaki Medical College University of Miyazaki
 Katsuhiro Toyama, MD
Ph: 81-98-585-2966
  Sendai
 Tohoku University Graduate School of Medicine
 Kiyoto Shiga, MD
Ph: 81-22-717-7304
 Email: kshiga@orl.med.tohoku.ac.jp
Nara
  Tenri
 Tenri Hospital
 Kazuhiko Shoji, MD
Ph: 81-74-363-5611
Niigata
  Joetsu
 Niigata Prefectural Central Hospital
 Yuichiro Sato, MD
Ph: 81-25-522-7711
Okayama
  Kurashiki
 Kawasaki Medical School
 Masako Uno, MD, PhD
Ph: 81-86-462-1111
Osaka
  Osaka
 Osaka City University
 Hiroyoshi Iguchi, MD
Ph: 81-66-645-3871
 Osaka General Medical Center
 Hiroshi Miyahara, MD
Ph: 81-6-6692-1201
  Osakasayama
 Kinki University School of Medicine
 Kyoichi Terao, MD, PhD
Ph: 81-723-66-0221
 Email: teraooto@med.kindai.ac.jp
Saitama
  Saitama
 Saitama Cancer Center
 Wataru Nishijima, MD
Ph: 81-48-722-1111
 Email: nishijima@cancer-c.pref.saitama.jp
Shimane
  Izumo
 Shimane University Hospital
 Hideyuki Kawauchi, MD
Ph: 81-853-20-2773
 Email: kawauchi@med.shimane-u.ac.jp
Shizuoka
  Hamamatsu
 Hamamatsu University School of Medicine
 Seiji Hosokawa, MD
Ph: 81-53-435-2252
 Email: seijih@hama-med.ac.jp
 Seirei Hamamatsu General Hospital
 Yusuhiro Hayashi, MD
Ph: 81-53-474-2222
Tochigi
  Utsunomiya
 Saiseikai Utsunomiya Hospital
 Taku Yamashita, MD
Ph: 81-28-626-5500
 Email: taku_yamashita@saimiya.com
Tokyo
  Hachioji
 Tokyo Medical University Hachioji Medical Center
 Tomoyuki Yoshida, MD
Ph: 81-42-665-5611
  Menguro-ku
 National Tokyo Medical Center
 Masato Fujii, MD
Ph: 81-3-3411-0379
 Email: fujiimasato@kankakuki.go.jp
  Mitaka-shi
 Kyorin University School of Medicine - Mitaka Campus
 Naoyuki Kohno, MD
Ph: 81-422-47-5511
 Email: sukohno@kyorin-u.ac.jp
  Ome-shi
 Ome Municipal General Hospital
 Takeshi Tsutsumi, MD
Ph: 81-428-22-3191
 Email: tsutsumi-t@mghp.ome.tokyo.jp
  Tokyo
 Cancer Institute Hospital of Japanese Foundation for Cancer Research
 Seiichi Yoshimoto, MD
Ph: 81-3-3520-0111
 Email: seyosimoto@jfcr.or.jp
 International Medical Center of Japan
 Niro Tayama, MD
Ph: 81-3-3202-7181
 Juntendo University School of Medicine
 Katsuhisa Ikeda, MD
Ph: 81-3-5802-1094
 Email: Ike@med.juntendo.ac.jp
 Keio University School of Medicine
 Toshiki Tomita, MD
Ph: 81-3-3353-1211 ext. 62441
 Email: t-tomita@sc.itc.keio.ac.jp
 Nippon Medical School
 Kazuhiko Yokoshima, MD
Ph: 81-3-3822-2131
 Email: kyok@nms.ac.jp
 Tokyo Medical and Dental University
 Seiji Kishimoto, MD
Ph: 81-3-5803-5911
 Email: kishi.hns@tmd.ac.jp
 Tokyo Medical University
 Hiroyuki Ito, MD
Ph: 81-3-3342-6111 ext. 5788
 Email: itohi@tokyo-med.ac.jp
Tottori
  Yonago-shi
 Tottori University Hospital
 Eiji Takeuchi, MD
Ph: 81-859-33-6627
 Email: mimiko@apple.zim.tottori-u.ac.jp
Wakayama
  Wakayama-shi
 Wakayama Medical University
 Shinji Tamura, MD
Ph: 81-73-441-0651
 Email: tamura@wakayama-med.ac.jp
Yamagata
  Yamanashi
 Interdiciplinary Graduate School of Medicine and Engineering
 Keisuke Masuyama, MD
Ph: 81-55-273-6769
 Email: mkeisuke@res.yamanashi-med.ac.jp

Registry Information
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
Trial Start Date 2006-04-01
Trial Completion Date 2012-03-31 (estimated)
Registered in ClinicalTrials.gov NCT00336947
Date Submitted to PDQ 2006-04-18
Information Last Verified 2008-03-30

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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