 |
|
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 - 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 500A 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 | | | |
Trial Sites
|
|
|
|
| Japan |
|
| Aichi |
|
| |
Nagoya |
|
| | | | | Aichi Cancer Center |
| | | Yasuhisa Hasegawa, MD | |
| | Email:
hasegawa@aichi-cc.jp |
|
| |
Toyoake |
|
| | | Fujita Health University |
| | | Kazuo Sakurai, MD | |
|
| Akita |
|
| |
Akita City |
|
| | | | Akita University Hospital |
| | | Shinsuke Suzuki, MD | |
| | Email:
shinsuke@med.akita-u.ac.jp |
|
| Chiba |
|
| |
Ichikawa |
|
| | | | Tokyo Dental College Ichikawa General Hospital |
| | | Yuichiro Okazaki, MD | |
|
| Ehime |
|
| |
Toon |
|
| | | | Ehime University Hospital |
| | | Masamitsu Hyodo, MD | |
| | Email:
hyodoma@m.ehime-u.ac.jp |
|
| Fukui |
|
| |
Fukui |
|
| | | | University of Fukui Hospital |
| | | Hideaki Tsuzuki, MD | |
| | Email:
hideaki@fmsrsa.fukui-med.ac.jp |
|
| Fukuoka |
|
| |
Fukuoka-shi |
|
| | | | National Kyushu Cancer Center |
| | | Kichinobu Tomita, MD | |
| | Email:
kctomita@nk-cc.go.jp |
|
| Fukushima |
|
| |
Fukushima |
|
| | | | Fukushima Medical University Hospital |
| | | Takashi Matsuzuka, MD | |
| | Email:
tmtzk@fmu.ac.jp |
|
| Gifu |
|
| |
Gifu-shi |
|
| | | | Gifu University Graduate School of Medicine |
| | | Keisuke Mizuta, MD | |
| | Email:
kmizuta@cc.gifu-u.ac.jp |
|
| Gunma |
|
| |
Maebashi |
|
| | | | Gunma University Graduate School of Medicine |
| | | Kazuaki Chikamatsu, MD | |
| | 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 | |
| | Email:
s.iwae@hp.pref.hyogo.jp |
|
| |
Himeji-shi |
|
| | | National Hospital Organization - Himeji Medical Center |
| | | Masaki Uozumi, MD | |
|
| Ishikawa |
|
| |
Kanazawa |
|
| | | | Kanazawa Medical University |
| | | Naohiro Wakisaka, MD | |
| | Email:
wakisaka@med.kanazawa-u.ac.jp |
|
| Iwate |
|
| |
Morioka-shi |
|
| | | | Iwate Medical University Hospital |
| | | Yoshihiro Kamada, MD | |
|
| Kagoshima |
|
| |
Kagoshima |
|
| | | | Kagoshima University |
| | | Tatsuya Fukuiwa, MD | |
| | Email:
silvian@m2.kufm.kagoshima-u.ac.jp |
|
| |
Kagoshima City |
|
| | | Kagoshima City Hospital |
| | | Yutaka Hanamure, MD | |
| | Email:
hanam@ml.kch.kagoshima.kagoshima.jp |
|
| Kanagawa |
|
| |
Yokohama |
|
| | | | Yokohama City University |
| | | Junichi Ishitoya, MD | |
| | Email:
ishitoya@med.yokohama-cu.ac.jp |
| | | Yokohama Rosai Hospital |
| | | Hideki Takemura, MD | |
|
| Kumamoto |
|
| |
Kumamoto City |
|
| | | | Kumamoto University Medical School |
| | | Ryosei Minoda, MD, PhD | |
|
| Mie |
|
| |
Tsu |
|
| | | | Mie University Graduate School of Medicine |
| | | Shinobu Arima, MD | |
| | Email:
shiouma@mbj.nifty.com |
|
| Miyazaki |
|
| |
Miyazaki-gun |
|
| | | | Miyazaki Medical College University of Miyazaki |
| | | Katsuhiro Toyama, MD | |
|
| |
Sendai |
|
| | | Tohoku University Graduate School of Medicine |
| | | Kiyoto Shiga, MD | |
| | Email:
kshiga@orl.med.tohoku.ac.jp |
|
| Nara |
|
| |
Tenri |
|
| | | | Tenri Hospital |
| | | Kazuhiko Shoji, MD | |
|
| Niigata |
|
| |
Joetsu |
|
| | | | Niigata Prefectural Central Hospital |
| | | Yuichiro Sato, MD | |
|
| Okayama |
|
| |
Kurashiki |
|
| | | | Kawasaki Medical School |
| | | Masako Uno, MD, PhD | |
|
| Osaka |
|
| |
Osaka |
|
| | | | Osaka City University |
| | | Hiroyoshi Iguchi, MD | |
| | | Osaka General Medical Center |
| | | Hiroshi Miyahara, MD | |
|
| |
Osakasayama |
|
| | | Kinki University School of Medicine |
| | | Kyoichi Terao, MD, PhD | |
| | Email:
teraooto@med.kindai.ac.jp |
|
| Saitama |
|
| |
Saitama |
|
| | | | Saitama Cancer Center |
| | | Wataru Nishijima, MD | |
| | Email:
nishijima@cancer-c.pref.saitama.jp |
|
| Shimane |
|
| |
Izumo |
|
| | | | Shimane University Hospital |
| | | Hideyuki Kawauchi, MD | |
| | Email:
kawauchi@med.shimane-u.ac.jp |
|
| Shizuoka |
|
| |
Hamamatsu |
|
| | | | Hamamatsu University School of Medicine |
| | | Seiji Hosokawa, MD | |
| | Email:
seijih@hama-med.ac.jp |
| | | Seirei Hamamatsu General Hospital |
| | | Yusuhiro Hayashi, MD | |
|
| Tochigi |
|
| |
Utsunomiya |
|
| | | | Saiseikai Utsunomiya Hospital |
| | | Taku Yamashita, MD | |
| | Email:
taku_yamashita@saimiya.com |
|
| Tokyo |
|
| |
Hachioji |
|
| | | | Tokyo Medical University Hachioji Medical Center |
| | | Tomoyuki Yoshida, MD | |
|
| |
Menguro-ku |
|
| | | National Tokyo Medical Center |
| | | Masato Fujii, MD | |
| | Email:
fujiimasato@kankakuki.go.jp |
|
| |
Mitaka-shi |
|
| | | Kyorin University School of Medicine - Mitaka Campus |
| | | Naoyuki Kohno, MD | |
| | Email:
sukohno@kyorin-u.ac.jp |
|
| |
Ome-shi |
|
| | | Ome Municipal General Hospital |
| | | Takeshi Tsutsumi, MD | |
| | Email:
tsutsumi-t@mghp.ome.tokyo.jp |
|
| |
Tokyo |
|
| | | Cancer Institute Hospital of Japanese Foundation for Cancer Research |
| | | Seiichi Yoshimoto, MD | |
| | Email:
seyosimoto@jfcr.or.jp |
| | | International Medical Center of Japan |
| | | Niro Tayama, MD | |
| | | Juntendo University School of Medicine |
| | | Katsuhisa Ikeda, MD | |
| | 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 | |
| | Email:
kyok@nms.ac.jp |
| | | Tokyo Medical and Dental University |
| | | Seiji Kishimoto, MD | |
| | 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 | |
| | Email:
mimiko@apple.zim.tottori-u.ac.jp |
|
| Wakayama |
|
| |
Wakayama-shi |
|
| | | | Wakayama Medical University |
| | | Shinji Tamura, MD | |
| | Email:
tamura@wakayama-med.ac.jp |
|
| Yamagata |
|
| |
Yamanashi |
|
| | | | Interdiciplinary Graduate School of Medicine and Engineering |
| | | Keisuke Masuyama, MD | |
| | 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.  Back to Top |
 |
