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| Sponsored by: |
University of Pennsylvania |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003777 |
Purpose
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.
| Condition | Intervention | Phase |
|
Head and Neck Cancer |
Drug: amifostine trihydrate Drug: cisplatin Drug: fluorouracil Procedure: radiation therapy Procedure: surgical procedure |
Phase II |
| MedlinePlus related topics: | Cancer Head and Neck Cancer |
| Drug Information available for: | Cisplatin Fluorouracil Amifostine Salicylsalicylic acid Sodium salicylate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma |
| Estimated Enrollment: | 35 |
| Study Start Date: | December 1998 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
The following sites are eligible:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Pennsylvania | |||||
| University of Pennsylvania Cancer Center | |||||
| Philadelphia, Pennsylvania, United States, 19104-4283 | |||||
| University of Pennsylvania |
| Study Chair: | Mitchell Machtay, MD | University of Pennsylvania |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000066906, UPCC-6398, ALZA-98-023-ii, NCI-V99-1518 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003777 |
| Health Authority: | United States: Federal Government |
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