Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00003580|
Recruitment Status : Completed
First Posted : May 25, 2004
Last Update Posted : June 26, 2013
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of amifostine in treating side effects of treatment in patients receiving radiation therapy and cisplatin for advanced head and neck cancer.
|Condition or disease||Intervention/treatment||Phase|
|Drug/Agent Toxicity by Tissue/Organ Head and Neck Cancer Oral Complications Radiation Toxicity||Drug: amifostine trihydrate Drug: cisplatin Radiation: radiation therapy||Phase 2|
OBJECTIVES: I. Determine the efficacy of amifostine in alleviating treatment related mucositis associated with targeted supradose cisplatin and concurrent radiotherapy (RADPLAT protocol) in patients with stage III or IV squamous cell carcinoma of the head and neck. II. Determine the efficacy of amifostine in alleviating other treatment related morbidities associated with this protocol in these patients.
OUTLINE: This is an open label, multicenter study of amifostine. Patients receive external beam radiotherapy 5 days a week for approximately 6.5-7.5 weeks. Concurrent with radiotherapy, patients receive amifostine IV over 10 minutes, 30 minutes prior to cisplatin, then cisplatin intra-arterially over 3-5 minutes. Chemotherapy and amifostine course is repeated every week for 4 weeks. Patients are followed at 1 month.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued into this study over 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase II Study - Efficacy of Amifostine in Alleviating Toxicity Associated With Targeted Supradose Cisplatin and Concomitant Radiation Therapy (RADPLAT) in Head and Neck Cancer|
|Study Start Date :||June 1998|
|Study Completion Date :||May 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003580
|United States, Tennessee|
|William F. Bowld Hospital|
|Memphis, Tennessee, United States, 38103|
|Study Chair:||K. Thomas Robbins, MD||University of Florida|