National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
Search
NCI Home Cancer Topics Clinical Trials Cancer Statistics Research & Funding News About NCI
Clinical Trials (PDQ®)
Patient VersionHealth Professional Version
Last Modified: 10/29/2007     First Published: 10/14/2005  
Page Options
Print This Page  Print This Page
E-Mail This Document  E-Mail This Document
Quick Links
Director's Corner

Dictionary of Cancer Terms

NCI Drug Dictionary

Funding Opportunities

NCI Publications

Advisory Boards and Groups

NIH Calendar of Events

Español
NCI Highlights
Imiquimod May Help to Prevent Vulvar Cancer

Sorafenib Increases Risk of High Blood Pressure

Past Highlights
HPV Vaccines for Cervical Cancer
BreastCancerTrials.org
Phase II Study of Docetaxel and Radiotherapy in Patients With Stage II or III Squamous Cell Carcinoma of the Larynx or Hypopharynx

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II


Treatment


Active


Not specified


Other


AICHI-UHA-HN04-02
NCT00243113

Objectives

Primary

  1. 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.

Secondary

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

Entry Criteria

Disease Characteristics:

  • 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


Prior/Concurrent Therapy:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior systemic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • No prior surgery

Patient Characteristics:

Age

  • See Disease Characteristics

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC > 3,000/mm3
  • Neutrophil count > 1,500/mm3
  • Hemoglobin > 10 g/dL
  • Platelet count > 100,000/mm3

Hepatic

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

Renal

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

Pulmonary

  • No severe pulmonary disease

Other

  • No severe neurologic disease

Expected Enrollment

50

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

Outcomes

Primary Outcome(s)

Objective response of primary tumor

Secondary Outcome(s)

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

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.

Trial Contact Information

Trial Lead Organizations

Aichi Cancer Center

Nobukazu Fuwa, Protocol chair
Ph: 81-52-762-6111

Trial Sites

Japan
  Hiroshima
 National Hospital Organization - Medical Center of Kure
 Makoto Shirane
Ph: 81-0823-22-3111
Aichi
  Nagoya
 Aichi Cancer Center
 Nobukazu Fuwa
Ph: 81-52-762-6111
Aomori
  Hirosaki
 Hirosaki University, School of Medicine
 Atsushi Namba, MD
Ph: 81-172-39-5099
 Email: namba@cc.hirosaki-u.ac.jp
Chiba
  Chiba City
 Chiba University
 Takashi Uno, MD
Ph: 81-43-226-2100
 Email: unotakas@faculty.chiba-u.jp
Kanagawa
  Yokohama
 Yokohama City University
 Mamoru Tsukuda, MD
Ph: 81-45-787-2687
 Email: mtsukuda@med.yokohama-cu.ac.jp
Nagano
  Matsumoto
 Shinshu University Health Center
 Naoto Shikama, MD, PhD
Ph: 81-263-37-2650
 Email: shikama@hsp.md.shinshu-u.ac.jp
Nara
  Nara
 Nara Medical University Cancer Center
 Katsunari Yane
Ph: 81-7442-9-8887
Okinawa
  Okinawa
 Graduate School of Medical Science at the University of Ryukyu
 Takafumi Toita
Ph: 81-98-895-1162
Shizuoka
  Hamamatsu
 Hamamatsu University School of Medicine
 Michiko Imai, MD, PhD
Ph: 81-53-435-2242

Registry Information
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
Trial Start Date 2004-06-01
Trial Completion Date 2009-05-30 (estimated)
Registered in ClinicalTrials.gov NCT00243113
Date Submitted to PDQ 2005-06-28
Information Last Verified 2008-03-30

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Back to TopBack to Top

A Service of the National Cancer Institute
Department of Health and Human Services National Institutes of Health USA.gov