Clinical trial NCT00336947: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-06-15
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disease-free survival
Secondary outcomes:
measure: Relapse-free survival
measure: Overall survival
measure: Adverse effects
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University
state: Aichi
city: Akita City
country: Japan
facility: Akita University Hospital
state: Akita
city: Ichikawa
country: Japan
facility: Tokyo Dental College Ichikawa General Hospital
state: Chiba
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Kyushu Cancer Center
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu University Graduate School of Medicine
state: Gifu
city: Maebashi
country: Japan
facility: Gunma University Graduate School of Medicine
state: Gunma
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Akashi City
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Himeji-shi
country: Japan
facility: National Hospital Organization - Himeji Medical Center
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa Medical University
state: Ishikawa
city: Morioka-shi
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Kagoshima City
country: Japan
facility: Kagoshima City Hospital
state: Kagoshima
city: Yokohama
country: Japan
facility: Yokohama Rosai Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University
state: Kanagawa
city: Kumamoto City
country: Japan
facility: Kumamoto University Medical School
state: Kumamoto
city: Tsu
country: Japan
facility: Mie University Graduate School of Medicine
state: Mie
city: Sendai
country: Japan
facility: Tohoku University Graduate School of Medicine
state: Miyagi
city: Miyazaki-gun
country: Japan
facility: Miyazaki Medical College University of Miyazaki
state: Miyazaki
city: Tenri
country: Japan
facility: Tenri Hospital
state: Nara
city: Joetsu
country: Japan
facility: Niigata Prefectural Central Hospital
state: Niigata
city: Kurashiki
country: Japan
facility: Kawasaki Medical School
state: Okayama
city: Osakasayama
country: Japan
facility: Kinki University School of Medicine
state: Osaka
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
city: Utsunomiya
country: Japan
facility: Saiseikai Utsunomiya Hospital
state: Tochigi
city: Hachioji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
state: Tokyo
city: Menguro-ku
country: Japan
facility: National Tokyo Medical Center
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Kyorin University School of Medicine - Mitaka Campus
state: Tokyo
city: Ome-shi
country: Japan
facility: Ome Municipal General Hospital
state: Tokyo
city: Yonago-shi
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University
state: Wakayama
city: Yamanashi
country: Japan
facility: Interdiciplinary Graduate School of Medicine and Engineering
state: Yamagata
city: Fukui
country: Japan
facility: University of Fukui Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Osaka
country: Japan
facility: Osaka City University
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Tokyo
country: Japan
facility: Juntendo University School of Medicine
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University
city: Tokyo
country: Japan
facility: Nippon Medical School
city: Tokyo
country: Japan
facility: Cancer Institute Hospital of Japanese Foundation for Cancer Research
city: Tokyo
country: Japan
facility: Tokyo Medical University
city: Tokyo
country: Japan
facility: Keio University School of Medicine
city: Tokyo
country: Japan
facility: International Medical Center of Japan
Study officials:
affiliation: Yokohama City University
name: Mamoru Tsukuda, MD
role: STUDY_CHAIR
References:
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.