AzTrials
AzTrials

Head and Neck CancerPhase 3NCT00336947

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

A Phase 3 study testing tegafur-gimeracil-oteracil potassium, tegafur-uracil and adjuvant therapy in people with Head and Neck Cancer, run by Yokohama City University at 48 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
tegafur-gimeracil-oteracil potassium, tegafur-uracil and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
500 participants
Where
48 sitesJapan
Study dates
Apr 2006to Mar 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

Japan48 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • Akita University Hospital

    Akita, Akita, 010-854

  • University of Fukui Hospital

    Fukui-shi, Fukui, 910-1193

  • National Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Gifu University Graduate School of Medicine

    Gifu, Gifu, 501-1194

  • Tokyo Medical University Hachioji Medical Center

    Hachiōji, Tokyo, 193-0998

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka, 430-8558

  • Hamamatsu University School of Medicine

    Hamamatsu, Shizuoka, 431-31

  • National Hospital Organization - Himeji Medical Center

    Himeji-shi, Hyōgo, 650-0017

  • Tokyo Dental College Ichikawa General Hospital

    Ichikawa, Chiba, 272-8513

  • Shimane University Hospital

    Izumo, Shimane, 693-8501

  • Niigata Prefectural Central Hospital

    Jōetsu, Niigata, 943-0192

  • Kagoshima University

    Kagoshima, Kagoshima-ken, 890-8520

  • Kagoshima City Hospital

    Kagoshima, Kagoshima-ken, 892-8580

  • Kanazawa Medical University

    Kanazawa, Ishikawa-ken, 920-0934

  • Kumamoto University Medical School

    Kumamoto, Kumamoto, 860-8556

  • Kawasaki Medical School

    Kurashiki, Okayama-ken, 701-01

  • Gunma University Graduate School of Medicine

    Maebashi, Gunma, 371-8511

  • National Tokyo Medical Center

    Menguro-ku, Tokyo, 152-8902

  • Kyorin University School of Medicine - Mitaka Campus

    Mitaka-shi, Tokyo, 181-8611

  • Miyazaki Medical College University of Miyazaki

    Miyazaki-gun, Miyazaki, 889-1692

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

  • Ome Municipal General Hospital

    Ome-shi, Tokyo, 198-0042

  • Osaka General Medical Center

    Osaka, Osaka, 558-0056

  • Osaka City University

    Osaka, Osaka, 558-8585

  • Saitama Cancer Center

    Saitama, Saitama, 362-0806

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8637

  • Kinki University School of Medicine

    Sayama, Osaka, 589-8511

  • Tohoku University Graduate School of Medicine

    Sendai, Miyagi, 980-8574

  • Tenri Hospital

    Tenri, Nara, 632-8552

  • Juntendo University School of Medicine

    Tokyo, Tokyo, 113-8421

  • Tokyo Medical and Dental University

    Tokyo, Tokyo, 113-8510

  • Nippon Medical School

    Tokyo, Tokyo, 113

  • Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Tokyo, Tokyo, 135-8550

  • Tokyo Medical University

    Tokyo, Tokyo, 160-0023

  • Keio University School of Medicine

    Tokyo, Tokyo, 160-8582

  • International Medical Center of Japan

    Tokyo, Tokyo, 162-8655

  • Ehime University Hospital

    Tōon, Ehime, 791-0295

  • Fujita Health University

    Toyoake, Aichi-ken, 470-11

  • Mie University Graduate School of Medicine

    Tsu, Mie-ken, 514

  • Saiseikai Utsunomiya Hospital

    Utsunomiya, Tochigi, 321-0974

  • Wakayama Medical University

    Wakayama, Wakayama, 641-8510

  • Interdiciplinary Graduate School of Medicine and Engineering

    Yamanashi, Yamagata, 409-3898

  • Yokohama Rosai Hospital

    Yokohama, Kanagawa, 222-0036

  • Yokohama City University

    Yokohama, Kanagawa, 232-0024

  • Tottori University Hospital

    Yonago-shi, Tottori, 683-8504

Other trials in Japan

About this study

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

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.

Read the 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.

Being tested
tegafur-gimeracil-oteracil potassium, tegafur-uracil, adjuvant therapy
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
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tegafur-gimeracil-oteracil potassiumDrug

  • tegafur-uracilDrug

  • adjuvant therapyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

Secondary outcomes (3)

  1. Relapse-free survival

  2. Overall survival

  3. Adverse effects

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionMar 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00336947
Sponsor's protocol ID
YCU-BRI-HN-05-01
Other IDs
CDR0000486874
Status last verified
Dec 2008
First submitted
13 Jun 2006
Last updated
15 May 2013
Results posted
No

Publications

  • 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.

    PubMed 25671770

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tegafur-gimeracil-oteracil potassium, tegafur-uracil and adjuvant therapy in people with Head and Neck Cancer, run by Yokohama City University at 48 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00336947, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in