Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx
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.
Head and Neck Cancer
Radiation: radiation therapy
|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|
- Objective response of primary tumor [ Designated as safety issue: No ]
- Local complete response rate [ Designated as safety issue: No ]
- Local progression-free survival at 2 years [ Designated as safety issue: No ]
- Local relapse-free survival [ Designated as safety issue: No ]
- Larynx preservation survival at 2 years [ Designated as safety issue: No ]
- Overall survival at 2 years [ Designated as safety issue: No ]
- Treatment completion rate [ Designated as safety issue: No ]
- Incidence of adverse effects [ Designated as safety issue: Yes ]
|Study Start Date:||June 2004|
|Study Completion Date:||November 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243113
|Aichi Cancer Center|
|Nagoya, Aichi, Japan, 464-8681|
|Hirosaki University, School of Medicine|
|Hirosaki, Aomori, Japan, 036-8562|
|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|
|Study Chair:||Nobukazu Fuwa||Aichi Cancer Center|