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

May 14, 2013 updated by: Yokohama City University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease-free survival

Secondary Outcome Measures

Outcome Measure
Overall survival
Relapse-free survival
Adverse effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yokohama City University

Investigators

  • Study Chair: Mamoru Tsukuda, MD, Yokohama city university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

June 13, 2006

First Submitted That Met QC Criteria

June 13, 2006

First Posted (Estimate)

June 15, 2006

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YCU-BRI-HN-05-01
  • CDR0000486874 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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