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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00336947
First received: June 13, 2006
Last updated: May 14, 2013
Last verified: December 2008
  Purpose

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
Head and Neck Cancer
Drug: tegafur-gimeracil-oteracil potassium
Drug: tegafur-uracil
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Adverse effects [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: April 2006
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336947

Locations
Japan
Aichi Cancer Center
Nagoya, Aichi, Japan, 464-8681
Fujita Health University
Toyoake, Aichi, Japan, 470-11
Akita University Hospital
Akita City, Akita, Japan, 010-854
Tokyo Dental College Ichikawa General Hospital
Ichikawa, Chiba, Japan, 272-8513
Ehime University Hospital
Toon, Ehime, Japan, 791-0295
National Kyushu Cancer Center
Fukuoka-shi, Fukuoka, Japan, 811-1395
Gifu University Graduate School of Medicine
Gifu-shi, Gifu, Japan, 501-1194
Gunma University Graduate School of Medicine
Maebashi, Gunma, Japan, 371-8511
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8637
Hyogo Cancer Center
Akashi City, Hyogo, Japan, 673-8558
National Hospital Organization - Himeji Medical Center
Himeji-shi, Hyogo, Japan, 650-0017
Kanazawa Medical University
Kanazawa, Ishikawa, Japan, 920-0934
Iwate Medical University Hospital
Morioka-shi, Iwate, Japan, 020-8505
Kagoshima City Hospital
Kagoshima City, Kagoshima, Japan, 892-8580
Yokohama Rosai Hospital
Yokohama, Kanagawa, Japan, 222-0036
Yokohama City University
Yokohama, Kanagawa, Japan, 232-0024
Kumamoto University Medical School
Kumamoto City, Kumamoto, Japan, 860-8556
Mie University Graduate School of Medicine
Tsu, Mie, Japan, 514
Tohoku University Graduate School of Medicine
Sendai, Miyagi, Japan, 980-8574
Miyazaki Medical College University of Miyazaki
Miyazaki-gun, Miyazaki, Japan, 889-1692
Tenri Hospital
Tenri, Nara, Japan, 632-8552
Niigata Prefectural Central Hospital
Joetsu, Niigata, Japan, 943-0192
Kawasaki Medical School
Kurashiki, Okayama, Japan, 701-01
Kinki University School of Medicine
Osakasayama, Osaka, Japan, 589-8511
Shimane University Hospital
Izumo, Shimane, Japan, 693-8501
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan, 431-31
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan, 430-8558
Saiseikai Utsunomiya Hospital
Utsunomiya, Tochigi, Japan, 321-0974
Tokyo Medical University Hachioji Medical Center
Hachioji, Tokyo, Japan, 193-0998
National Tokyo Medical Center
Menguro-ku, Tokyo, Japan, 152-8902
Kyorin University School of Medicine - Mitaka Campus
Mitaka-shi, Tokyo, Japan, 181-8611
Ome Municipal General Hospital
Ome-shi, Tokyo, Japan, 198-0042
Tottori University Hospital
Yonago-shi, Tottori, Japan, 683-8504
Wakayama Medical University
Wakayama-shi, Wakayama, Japan, 641-8510
Interdiciplinary Graduate School of Medicine and Engineering
Yamanashi, Yamagata, Japan, 409-3898
University of Fukui Hospital
Fukui, Japan, 910-1193
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Kagoshima University
Kagoshima, Japan, 890-8520
Osaka General Medical Center
Osaka, Japan, 558-0056
Osaka City University
Osaka, Japan, 558-8585
Saitama Cancer Center
Saitama, Japan, 362-0806
Keio University School of Medicine
Tokyo, Japan, 160-8582
Tokyo Medical and Dental University
Tokyo, Japan, 113-8510
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, Japan, 135-8550
Tokyo Medical University
Tokyo, Japan, 160-0023
Juntendo University School of Medicine
Tokyo, Japan, 113-8421
Nippon Medical School
Tokyo, Japan, 113
International Medical Center of Japan
Tokyo, Japan, 162-8655
Sponsors and Collaborators
Yokohama City University
Investigators
Study Chair: Mamoru Tsukuda, MD Yokohama City University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00336947     History of Changes
Other Study ID Numbers: YCU-BRI-HN-05-01, CDR0000486874
Study First Received: June 13, 2006
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Tegafur
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014