Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx
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|ClinicalTrials.gov Identifier: NCT00243113|
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : March 26, 2013
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 or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: docetaxel Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2004|
|Primary Completion Date :||March 2008|
|Study Completion Date :||November 2008|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|