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

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

Outcomes

Objective response of primary tumor

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

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

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