Spots Global Cancer Trial Database for Randomized Amifostine For SCCHN
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Trial Identification
Brief Title: Randomized Amifostine For SCCHN
Official Title: Phase II, Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With (Arm A) or Without (Arm B) Daily Subcutaneous Amifostine in Patients With Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck
Study ID: NCT00095927
Study Description
Brief Summary: This research study is studying a drug called Amifostine as a treatment for squamous cell carcinoma in the head and/or neck area.
Detailed Description: Amifostine is a drug that is used to treat moderate to severe xerostomia (dry mouth) for those who receive radiation therapy for head and neck cancer. It was approved by the FDA for use intravenously. This study plans to examine the effects of xerostomia when Amifostine is used subcutaneously (by injection). Amifostine has been seen to be effective when used to combat the effects of dry mouth, but also has some side effects which are listed later in this consent form. The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel (Taxo 1). This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Goodall Hospital, Sanford, Maine, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Bethke Cancer Center at Emerson Hospital, Concord, Massachusetts, United States
Mass General/North Shore Cancer Center, Danvers, Massachusetts, United States
Saint Anne's Hospital - Fall River, Fall River, Massachusetts, United States
Lowell General Hospital, Lowell, Massachusetts, United States
Wentworth Douglass Hospital, Dover, New Hampshire, United States
Contact Details
Name: Robert I. Haddad, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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