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| ID | Type | Description | Link |
|---|---|---|---|
| AICHI-UHA-HN04-02 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response of primary tumor |
| Measure | Description | Time Frame |
|---|---|---|
| Local complete response rate | ||
| Local progression-free survival at 2 years | ||
| Local relapse-free survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the larynx or hypopharynx
Solitary lymph node metastasis located in level II-III allowed
Age 70 and over OR meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Nobukazu Fuwa | Aichi Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| Hirosaki University, School of Medicine |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Larynx preservation survival at 2 years |
| Overall survival at 2 years |
| Treatment completion rate |
| Incidence of adverse effects |
| Hirosaki |
| Aomori |
| 036-8562 |
| Japan |
| Chiba University | Chiba | Chiba | 260-8677 | Japan |
| Yokohama City University | Yokohama | Kanagawa | 236-0004 | Japan |
| Shinshu University Health Center | Matsumoto | Nagano | 390-8621 | Japan |
| Nara Medical University Cancer Center | Nara | Nara | 634-8522 | Japan |
| Graduate School of Medical Science at the University of Ryukyu | Okinawa | Okinawa | 903-0215 | Japan |
| Hamamatsu University School of Medicine | Hamamatsu | Shizuoka | 431-31 | Japan |
| National Hospital Organization - Medical Center of Kure | Hiroshima | 737-0023 | Japan |
| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |