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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000389425 | Registry Identifier | PDQ (Physician Data Query) |
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RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining fluorouracil and cisplatin with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil and cisplatin together with radiation therapy works in treating patients with stage II, stage III, or stage IV nasopharyngeal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive chemotherapy comprising fluorouracil IV continuously on days 1-5 and cisplatin IV continuously on days 6-7. Beginning 2-3 days after the completion of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 4 weeks. With 2-3 days between each course, patients receive a second course of chemotherapy, undergo a second course of radiotherapy, and then receive a third course of chemotherapy. Treatment continues in the absence of unacceptable toxicity or disease progression.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 2 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| fluorouracil | Drug | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival at 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | ||
| Response rate | ||
| Treatment completion rate |
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DISEASE CHARACTERISTICS:
Histologically confirmed nasopharyngeal cancer (NPC)
Type I-III disease by WHO classification
Stage IIB-IVB disease by TNM classification with no distant metastases by chest x-ray, liver ultrasonography or CT scan, and bone scintigraphy
Progression range of primary lesion evaluated by MRI and pharyngeal fiberoptic endoscopy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
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 |
|---|---|---|---|---|---|---|
| National Hospital Organization - Medical Center of Kure | Hiroshima | 737-0023 | Japan | |||
| Kanazawa University |
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| Incidence of adverse effects |
| Kanazawa |
| 920-8641 |
| Japan |
| Kyoto Prefectural University of Medicine | Kyoto | 602 | Japan |
| Aichi Cancer Center | Nagoya | 464-8681 | Japan |
| Nara Medical University Cancer Center | Nara | 634-8522 | Japan |
| Graduate School of Medical Science at the University of Ryukyu | Okinawa | 903-0215 | Japan |
| Mie University School of Medicine | Tsu | 514-8507 | Japan |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
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