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

Phase 2

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00243113
• Lead Sponsor: Aichi Cancer Center

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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

* 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-10-20
• Study First Submitted QC: 2005-10-20
• Study First Posted: 2005-10-21
• Status Verified: 2008-03
• Primary Completion: 2008-03
• Study Completion: 2008-11
• Last Update Submitted: 2013-03-25
• Last Update Posted: 2013-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response of primary tumor

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Chiba University; 🇯🇵 Chiba City, Chiba, Japan

Aichi Cancer Center; 🇯🇵 Nagoya, Aichi, Japan

Hirosaki University, School of Medicine; 🇯🇵 Hirosaki, Aomori, Japan

Yokohama City University; 🇯🇵 Yokohama, Kanagawa, Japan

Shinshu University Health Center; 🇯🇵 Matsumoto, Nagano, Japan

Hamamatsu University School of Medicine; 🇯🇵 Hamamatsu, Shizuoka, Japan

National Hospital Organization - Medical Center of Kure; 🇯🇵 Hiroshima, Japan

Nara Medical University Cancer Center; 🇯🇵 Nara, Japan

Graduate School of Medical Science at the University of Ryukyu; 🇯🇵 Okinawa, Japan