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

NCT00336947 | Unknown Phase 3

• 2 other identifiers: YCU-BRI-HN-05-01CDR0000486874
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 48

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.

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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

Secondary Outcomes (3)

• Relapse-free survival

• Overall survival

• Adverse effects

Interventions

tegafur-gimeracil-oteracil potassium DRUG

tegafur-uracil DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yokohama City University: lead

Study Sites (48)

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

Location

Fujita Health University

Toyoake, Aichi-ken, 470-11, Japan

Location

Akita University Hospital

Akita, Akita, 010-854, Japan

Location

Tokyo Dental College Ichikawa General Hospital

Ichikawa, Chiba, 272-8513, Japan

Location

Ehime University Hospital

Tōon, Ehime, 791-0295, Japan

Location

University of Fukui Hospital

Fukui-shi, Fukui, 910-1193, Japan

Location

National Kyushu Cancer Center

Fukuoka, Fukuoka, 811-1395, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Gifu University Graduate School of Medicine

Gifu, Gifu, 501-1194, Japan

Location

Gunma University Graduate School of Medicine

Maebashi, Gunma, 371-8511, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8637, Japan

Location

Hyogo Cancer Center

Akashi, Hyōgo, 673-8558, Japan

Location

National Hospital Organization - Himeji Medical Center

Himeji-shi, Hyōgo, 650-0017, Japan

Location

Kanazawa Medical University

Kanazawa, Ishikawa-ken, 920-0934, Japan

Location

Iwate Medical University Hospital

Morioka, Iwate, 020-8505, Japan

Location

Kagoshima University

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

Kagoshima City Hospital

Kagoshima, Kagoshima-ken, 892-8580, Japan

Location

Yokohama Rosai Hospital

Yokohama, Kanagawa, 222-0036, Japan

Location

Yokohama City University

Yokohama, Kanagawa, 232-0024, Japan

Location

Kumamoto University Medical School

Kumamoto, Kumamoto, 860-8556, Japan

Location

Mie University Graduate School of Medicine

Tsu, Mie-ken, 514, Japan

Location

Tohoku University Graduate School of Medicine

Sendai, Miyagi, 980-8574, Japan

Location

Miyazaki Medical College University of Miyazaki

Miyazaki-gun, Miyazaki, 889-1692, Japan

Location

Tenri Hospital

Tenri, Nara, 632-8552, Japan

Location

Niigata Prefectural Central Hospital

Jōetsu, Niigata, 943-0192, Japan

Location

Kawasaki Medical School

Kurashiki, Okayama-ken, 701-01, Japan

Location

Osaka General Medical Center

Osaka, Osaka, 558-0056, Japan

Location

Osaka City University

Osaka, Osaka, 558-8585, Japan

Location

Kinki University School of Medicine

Sayama, Osaka, 589-8511, Japan

Location

Saitama Cancer Center

Saitama, Saitama, 362-0806, Japan

Location

Shimane University Hospital

Izumo, Shimane, 693-8501, Japan

Location

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, 430-8558, Japan

Location

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-31, Japan

Location

Saiseikai Utsunomiya Hospital

Utsunomiya, Tochigi, 321-0974, Japan

Location

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo, 193-0998, Japan

Location

National Tokyo Medical Center

Menguro-ku, Tokyo, 152-8902, Japan

Location

Kyorin University School of Medicine - Mitaka Campus

Mitaka-shi, Tokyo, 181-8611, Japan

Location

Ome Municipal General Hospital

Ome-shi, Tokyo, 198-0042, Japan

Location

Juntendo University School of Medicine

Tokyo, Tokyo, 113-8421, Japan

Location

Tokyo Medical and Dental University

Tokyo, Tokyo, 113-8510, Japan

Location

Nippon Medical School

Tokyo, Tokyo, 113, Japan

Location

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Tokyo, Tokyo, 135-8550, Japan

Location

Tokyo Medical University

Tokyo, Tokyo, 160-0023, Japan

Location

Keio University School of Medicine

Tokyo, Tokyo, 160-8582, Japan

Location

International Medical Center of Japan

Tokyo, Tokyo, 162-8655, Japan

Location

Tottori University Hospital

Yonago-shi, Tottori, 683-8504, Japan

Location

Wakayama Medical University

Wakayama, Wakayama, 641-8510, Japan

Location

Interdiciplinary Graduate School of Medicine and Engineering

Yamanashi, Yamagata, 409-3898, Japan

Location

Related Publications (1)

• 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.

  PMID: 25671770 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Tegafur; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Mamoru Tsukuda, MD

  Yokohama City University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 15, 2006
• Study Start: April 1, 2006
• Primary Completion: March 1, 2012
• Last Updated: May 15, 2013

Record last verified: 2008-12

Locations

JP (48)