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Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: October 20, 2005
Last updated: March 25, 2013
Last verified: March 2008

RATIONALE: Drugs used in chemotherapy, such as docetaxel 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 docetaxel together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy works in treating patients with stage II or stage III cancer of the larynx or hypopharynx.

Condition Intervention Phase
Head and Neck Cancer
Drug: docetaxel
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Institutional Phase II Study of Weekly Docetaxel and Concurrent Radiotherapy for Laryngeal and Hypopharyngeal Cancer in the Group of Elderly and/or Patients With Medical Illness

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Objective response of primary tumor

Secondary Outcome Measures:
  • Local complete response rate
  • Local progression-free survival at 2 years
  • Local relapse-free survival
  • Larynx preservation survival at 2 years
  • Overall survival at 2 years
  • Treatment completion rate
  • Incidence of adverse effects

Estimated Enrollment: 50
Study Start Date: June 2004
Study Completion Date: November 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:



  • Determine the objective response of the primary tumor in patients with stage II or III squamous cell carcinoma of the larynx or hypopharynx treated with docetaxel and radiotherapy.


  • Determine the local relapse-free survival of patients treated with this regimen.
  • Determine the larynx-preservation survival of patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the protocol completion rate in patients treated with this regimen.
  • Determine the adverse effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, and 29-33.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed squamous cell carcinoma of the larynx or hypopharynx

    • Stage II or III disease
  • Solitary lymph node metastasis located in level II-III allowed
  • Age 70 and over OR meets 1 of the following criteria:

    • Creatinine clearance 30-60 mL/min
    • History of platinum allergy
    • Diagnosis of unstable angina
    • Ineligible for systemic chemotherapy, including high-dose platinum-containing regimens



  • See Disease Characteristics

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • WBC > 3,000/mm^3
  • Neutrophil count > 1,500/mm^3
  • Hemoglobin > 10 g/dL
  • Platelet count > 100,000/mm^3


  • AST and ALT ≤ 2.0 times upper limit of normal
  • Bilirubin < 2.0 mg/dL
  • No severe liver disease


  • See Disease Characteristics
  • Creatinine clearance ≥ 30 mL/min
  • No severe renal disease


  • No severe pulmonary disease


  • No severe neurologic disease


Biologic therapy

  • Not specified


  • No prior systemic chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy


  • No prior surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00243113

Aichi Cancer Center
Nagoya, Aichi, Japan, 464-8681
Hirosaki University, School of Medicine
Hirosaki, Aomori, Japan, 036-8562
Chiba University
Chiba City, Chiba, Japan, 260-8677
Yokohama City University
Yokohama, Kanagawa, Japan, 236-0004
Shinshu University Health Center
Matsumoto, Nagano, Japan, 390-8621
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan, 431-31
National Hospital Organization - Medical Center of Kure
Hiroshima, Japan, 737-0023
Nara Medical University Cancer Center
Nara, Japan, 634-8522
Graduate School of Medical Science at the University of Ryukyu
Okinawa, Japan, 903-0215
Sponsors and Collaborators
Aichi Cancer Center
Study Chair: Nobukazu Fuwa Aichi Cancer Center
  More Information Identifier: NCT00243113     History of Changes
Other Study ID Numbers: CDR0000439499
Study First Received: October 20, 2005
Last Updated: March 25, 2013

Keywords provided by National Cancer Institute (NCI):
stage II squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017