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

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
tegafur-gimeracil-oteracil potassium
tegafur-uracil
adjuvant therapy
Sponsored by
Yokohama City University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aichi Cancer Center
  • Fujita Health University
  • Akita University Hospital
  • Tokyo Dental College Ichikawa General Hospital
  • Ehime University Hospital
  • National Kyushu Cancer Center
  • Gifu University Graduate School of Medicine
  • Gunma University Graduate School of Medicine
  • Hokkaido University Hospital
  • Hyogo Cancer Center
  • National Hospital Organization - Himeji Medical Center
  • Kanazawa Medical University
  • Iwate Medical University Hospital
  • Kagoshima City Hospital
  • Yokohama Rosai Hospital
  • Yokohama City University
  • Kumamoto University Medical School
  • Mie University Graduate School of Medicine
  • Tohoku University Graduate School of Medicine
  • Miyazaki Medical College University of Miyazaki
  • Tenri Hospital
  • Niigata Prefectural Central Hospital
  • Kawasaki Medical School
  • Kinki University School of Medicine
  • Shimane University Hospital
  • Seirei Hamamatsu General Hospital
  • Hamamatsu University School of Medicine
  • Saiseikai Utsunomiya Hospital
  • Tokyo Medical University Hachioji Medical Center
  • National Tokyo Medical Center
  • Kyorin University School of Medicine - Mitaka Campus
  • Ome Municipal General Hospital
  • Tottori University Hospital
  • Wakayama Medical University
  • Interdiciplinary Graduate School of Medicine and Engineering
  • University of Fukui Hospital
  • Fukushima Medical University Hospital
  • Kagoshima University
  • Osaka General Medical Center
  • Osaka City University
  • Saitama Cancer Center
  • Juntendo University School of Medicine
  • Tokyo Medical and Dental University
  • Nippon Medical School
  • Cancer Institute Hospital of Japanese Foundation for Cancer Research
  • Tokyo Medical University
  • Keio University School of Medicine
  • International Medical Center of Japan

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

Relapse-free survival
Overall survival
Adverse effects

Full Information

First Posted
June 13, 2006
Last Updated
May 14, 2013
Sponsor
Yokohama City University
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1. Study Identification

Unique Protocol Identification Number
NCT00336947
Brief Title
S-1 or Tegafur-Uracil in Treating Patients With Previously Treated Stage III or Stage IV Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Yokohama City University

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tegafur-gimeracil-oteracil potassium
Intervention Type
Drug
Intervention Name(s)
tegafur-uracil
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Disease-free survival
Secondary Outcome Measure Information:
Title
Relapse-free survival
Title
Overall survival
Title
Adverse effects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mamoru Tsukuda, MD
Organizational Affiliation
Yokohama City University
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Fujita Health University
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-11
Country
Japan
Facility Name
Akita University Hospital
City
Akita City
State/Province
Akita
ZIP/Postal Code
010-854
Country
Japan
Facility Name
Tokyo Dental College Ichikawa General Hospital
City
Ichikawa
State/Province
Chiba
ZIP/Postal Code
272-8513
Country
Japan
Facility Name
Ehime University Hospital
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
National Kyushu Cancer Center
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Gifu University Graduate School of Medicine
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Gunma University Graduate School of Medicine
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8637
Country
Japan
Facility Name
Hyogo Cancer Center
City
Akashi City
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
National Hospital Organization - Himeji Medical Center
City
Himeji-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Kanazawa Medical University
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-0934
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Kagoshima City Hospital
City
Kagoshima City
State/Province
Kagoshima
ZIP/Postal Code
892-8580
Country
Japan
Facility Name
Yokohama Rosai Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Facility Name
Yokohama City University
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Kumamoto University Medical School
City
Kumamoto City
State/Province
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Mie University Graduate School of Medicine
City
Tsu
State/Province
Mie
ZIP/Postal Code
514
Country
Japan
Facility Name
Tohoku University Graduate School of Medicine
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Miyazaki Medical College University of Miyazaki
City
Miyazaki-gun
State/Province
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Tenri Hospital
City
Tenri
State/Province
Nara
ZIP/Postal Code
632-8552
Country
Japan
Facility Name
Niigata Prefectural Central Hospital
City
Joetsu
State/Province
Niigata
ZIP/Postal Code
943-0192
Country
Japan
Facility Name
Kawasaki Medical School
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
701-01
Country
Japan
Facility Name
Kinki University School of Medicine
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Shimane University Hospital
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Seirei Hamamatsu General Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-8558
Country
Japan
Facility Name
Hamamatsu University School of Medicine
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-31
Country
Japan
Facility Name
Saiseikai Utsunomiya Hospital
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
321-0974
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
National Tokyo Medical Center
City
Menguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Kyorin University School of Medicine - Mitaka Campus
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Ome Municipal General Hospital
City
Ome-shi
State/Province
Tokyo
ZIP/Postal Code
198-0042
Country
Japan
Facility Name
Tottori University Hospital
City
Yonago-shi
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Wakayama Medical University
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Interdiciplinary Graduate School of Medicine and Engineering
City
Yamanashi
State/Province
Yamagata
ZIP/Postal Code
409-3898
Country
Japan
Facility Name
University of Fukui Hospital
City
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Kagoshima University
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-0056
Country
Japan
Facility Name
Osaka City University
City
Osaka
ZIP/Postal Code
558-8585
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Juntendo University School of Medicine
City
Tokyo
ZIP/Postal Code
113-8421
Country
Japan
Facility Name
Tokyo Medical and Dental University
City
Tokyo
ZIP/Postal Code
113-8510
Country
Japan
Facility Name
Nippon Medical School
City
Tokyo
ZIP/Postal Code
113
Country
Japan
Facility Name
Cancer Institute Hospital of Japanese Foundation for Cancer Research
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Tokyo Medical University
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Keio University School of Medicine
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
International Medical Center of Japan
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25671770
Citation
Tsukahara K, Kubota A, Hasegawa Y, Takemura H, Terada T, Taguchi T, Nagahara K, Nakatani H, Yoshino K, Higaki Y, Iwae S, Beppu T, Hanamure Y, Tomita K, Kohno N, Kawabata K, Fukushima M, Teramukai S, Fujii M; ACTS-HNC group. Randomized phase III trial of adjuvant chemotherapy with S-1 after curative treatment in patients with squamous-cell carcinoma of the head and neck (ACTS-HNC). PLoS One. 2015 Feb 11;10(2):e0116965. doi: 10.1371/journal.pone.0116965. eCollection 2015.
Results Reference
derived

Learn more about this trial

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

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