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

Sponsor

Yokohama City University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00336947

Collaborator

(none)

500

Enrollment

Locations

10.4

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: tegafur-gimeracil-oteracil potassium Drug: tegafur-uracil Procedure: adjuvant therapy	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

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

Study Start Date :

Apr 1, 2006

Anticipated Primary Completion Date :

Mar 1, 2012

Outcome Measures

Primary Outcome Measures

Disease-free survival []

Secondary Outcome Measures

Relapse-free survival []
Overall survival []
Adverse effects []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aichi Cancer Center	Nagoya	Aichi	Japan	464-8681
2	Fujita Health University	Toyoake	Aichi	Japan	470-11
3	Akita University Hospital	Akita City	Akita	Japan	010-854
4	Tokyo Dental College Ichikawa General Hospital	Ichikawa	Chiba	Japan	272-8513
5	Ehime University Hospital	Toon	Ehime	Japan	791-0295
6	National Kyushu Cancer Center	Fukuoka-shi	Fukuoka	Japan	811-1395
7	Gifu University Graduate School of Medicine	Gifu-shi	Gifu	Japan	501-1194
8	Gunma University Graduate School of Medicine	Maebashi	Gunma	Japan	371-8511
9	Hokkaido University Hospital	Sapporo	Hokkaido	Japan	060-8637
10	Hyogo Cancer Center	Akashi City	Hyogo	Japan	673-8558
11	National Hospital Organization - Himeji Medical Center	Himeji-shi	Hyogo	Japan	650-0017
12	Kanazawa Medical University	Kanazawa	Ishikawa	Japan	920-0934
13	Iwate Medical University Hospital	Morioka-shi	Iwate	Japan	020-8505
14	Kagoshima City Hospital	Kagoshima City	Kagoshima	Japan	892-8580
15	Yokohama Rosai Hospital	Yokohama	Kanagawa	Japan	222-0036
16	Yokohama City University	Yokohama	Kanagawa	Japan	232-0024
17	Kumamoto University Medical School	Kumamoto City	Kumamoto	Japan	860-8556
18	Mie University Graduate School of Medicine	Tsu	Mie	Japan	514
19	Tohoku University Graduate School of Medicine	Sendai	Miyagi	Japan	980-8574
20	Miyazaki Medical College University of Miyazaki	Miyazaki-gun	Miyazaki	Japan	889-1692
21	Tenri Hospital	Tenri	Nara	Japan	632-8552
22	Niigata Prefectural Central Hospital	Joetsu	Niigata	Japan	943-0192
23	Kawasaki Medical School	Kurashiki	Okayama	Japan	701-01
24	Kinki University School of Medicine	Osakasayama	Osaka	Japan	589-8511
25	Shimane University Hospital	Izumo	Shimane	Japan	693-8501
26	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka	Japan	430-8558
27	Hamamatsu University School of Medicine	Hamamatsu	Shizuoka	Japan	431-31
28	Saiseikai Utsunomiya Hospital	Utsunomiya	Tochigi	Japan	321-0974
29	Tokyo Medical University Hachioji Medical Center	Hachioji	Tokyo	Japan	193-0998
30	National Tokyo Medical Center	Menguro-ku	Tokyo	Japan	152-8902
31	Kyorin University School of Medicine - Mitaka Campus	Mitaka-shi	Tokyo	Japan	181-8611
32	Ome Municipal General Hospital	Ome-shi	Tokyo	Japan	198-0042
33	Tottori University Hospital	Yonago-shi	Tottori	Japan	683-8504
34	Wakayama Medical University	Wakayama-shi	Wakayama	Japan	641-8510
35	Interdiciplinary Graduate School of Medicine and Engineering	Yamanashi	Yamagata	Japan	409-3898
36	University of Fukui Hospital	Fukui		Japan	910-1193
37	Fukushima Medical University Hospital	Fukushima		Japan	960-1295
38	Kagoshima University	Kagoshima		Japan	890-8520
39	Osaka General Medical Center	Osaka		Japan	558-0056
40	Osaka City University	Osaka		Japan	558-8585
41	Saitama Cancer Center	Saitama		Japan	362-0806
42	Juntendo University School of Medicine	Tokyo		Japan	113-8421
43	Tokyo Medical and Dental University	Tokyo		Japan	113-8510
44	Nippon Medical School	Tokyo		Japan	113
45	Cancer Institute Hospital of Japanese Foundation for Cancer Research	Tokyo		Japan	135-8550
46	Tokyo Medical University	Tokyo		Japan	160-0023
47	Keio University School of Medicine	Tokyo		Japan	160-8582
48	International Medical Center of Japan	Tokyo		Japan	162-8655