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Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 28, 2008
Last updated: February 25, 2011
Last verified: February 2011

RATIONALE: Drugs used in chemotherapy, such as docetaxel, S-1, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and S-1 together with radiation therapy and low-dose cisplatin works in treating patients with stage III or stage IV head and neck cancer.

Condition Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Drug: docetaxel
Drug: tegafur-gimeracil-oteracil potassium
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase ll Trial of Induction Docetaxel and S-1 Followed by Concomitant Radiotherapy With Low-dose Daily Cisplatin in Locally Advanced Head and Neck Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate (complete or partial response) as assessed by RECIST criteria

Secondary Outcome Measures:
  • Progression-free survival
  • Overall survival
  • Toxicity as assessed by NCI CTCAE v3.0 criteria

Estimated Enrollment: 46
Study Start Date: November 2006
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:



  • To assess the response rate in patients with stage III or IV head and neck cancer treated with induction therapy comprising docetaxel and S-1 followed by radiotherapy and low-dose cisplatin.


  • To assess the effect of this regimen on survival and locoregional and systemic control rates in these patients.


  • Induction chemotherapy: Patients receive oral S-1 twice daily on days 1-14 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
  • Chemoradiotherapy: Patients receive low-dose cisplatin IV once daily and undergo radiotherapy 5 days a week for 7 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 18 months.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Pathologically confirmed head and neck cancer arising from the oral cavity, oropharynx, hypopharynx, or nasopharynx, including any of the following subtypes:

    • Squamous cell carcinoma
    • Poorly differentiated carcinoma
    • Lymphoepithelioma
  • Locally advanced disease (stage III or IV [M0] disease)
  • At least 1 unidimensionally measurable index lesion


  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3.0 times ULN
  • AST and ALT ≤ 3.0 times ULN
  • Creatinine ≤ 1.5 times ULN
  • No concurrent serious systemic disorder that, in the opinion of investigator, would compromise the patient's ability to complete the study
  • No serious cardiac condition, including any of the following:

    • Myocardial infarction within the past 6 months
    • Angina
    • NYHA class III-IV heart disease
  • No active infection requiring IV antibiotics, including active tuberculosis or HIV
  • No other malignancy within the past 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
  • Able to comply with protocol or study procedures


  • No prior radiotherapy or chemotherapy
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Please refer to this study by its identifier: NCT00625937

Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Joo-Hang Kim, MD    82-2-2228-8131   
Sponsors and Collaborators
Yonsei University
Study Chair: Joo-Hang Kim, MD Yonsei University
  More Information Identifier: NCT00625937     History of Changes
Other Study ID Numbers: CDR0000582621
Study First Received: February 28, 2008
Last Updated: February 25, 2011

Keywords provided by National Cancer Institute (NCI):
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage III verrucous carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage III lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
tongue cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites processed this record on April 27, 2017