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| ID | Type | Description | Link |
|---|---|---|---|
| UPCC-6398 | |||
| ALZA-98-023-ii | |||
| NCI-V99-1518 |
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PI left institution
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RATIONALE: Drugs used in chemotherapy use 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. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.
OBJECTIVES:
OUTLINE: Patients undergo surgical resection of gross disease (if not already done) followed by 4-6 weeks of rest. Patients receive radiotherapy over 5 consecutive days on weeks 1, 2, 4, and 5. Intravenous cisplatin is administered on days 1-3 and 29-31. Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy. Patients receive fluorouracil IV continuously on days 1-4 and 29-32.
Patients are followed every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amifostine trihydrate | Drug | |||
| cisplatin | Drug | |||
| fluorouracil | Drug | |||
| surgical procedure | Procedure | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent or new primary squamous cell carcinoma of the head and neck occurring in a previously irradiated field
Pathologic stage of recurrence must be rT3-4 and/or rN2-3
The following sites are eligible:
No primary tumor of the nasopharynx
Must be eligible for or have undergone complete resection which leaves behind no gross residual disease
Must have prior head and neck irradiation of 45-75 Gy
Lifetime spinal cord radiotherapy dose no greater than 50 Gy
No ongoing RTOG late morbidity of grade 3 or greater (unless correctable by surgery)
No active acute radiation mucositis from previous radiotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Machtay, MD | Abramson Cancer Center at Penn Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104-4283 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009062 | Mouth Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D004999 | Amifostine |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D063086 | Organothiophosphates |
| D010755 | Organophosphates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D009946 | Organothiophosphorus Compounds |
| D013457 | Sulfur Compounds |
| 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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