Spots Global Cancer Trial Database for Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx
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Trial Identification
Brief Title: Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx
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 ID: NCT00243113
Conditions
Study Description
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aichi Cancer Center, Nagoya, Aichi, Japan
Hirosaki University, School of Medicine, Hirosaki, Aomori, Japan
Chiba University, Chiba City, Chiba, 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
Contact Details
Name: Nobukazu Fuwa
Affiliation: Aichi Cancer Center
Role: STUDY_CHAIR
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