Status:
COMPLETED
Amifostine for Head and Neck Irradiation in Lymphoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Conditions:
Lymphoma
Hodgkin's Disease
Eligibility:
All Genders
35+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is determine the effects (good and bad) amifostine has on radiation-induced side effects of lymphoma treatment.
Detailed Description
Patients will be randomized into one of two study groups. One study group will receive amifostine prior to daily radiation therapy and the other group will receive radiation therapy alone. Amifostine...
Eligibility Criteria
Inclusion
- Patients must be 35 years or older
- Histologically confirmed Hodgkin's disease or non-Hodgkin's lymphoma receiving radiation therapy to the head and neck area.
- Involvement of one or more of the following sites: cervical node, supraclavicular node, pre-auricular node, submental node, any salivary glands, any parts of the oral cavity, or any parts of the oropharynx.
Exclusion
- Prior history of head and neck malignancies
- Prior radiation therapy to the head and neck region
- Patients with stage I Hodgkin's disease receiving radiation therapy alone
- Pregnant or lactating women
- Myocardial infarction within the 6 months of enrollment
- Clinically evident pulmonary insufficiency, except for patients with exertional dyspnea related to chest tumor itself.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00136474
Start Date
May 1 2003
End Date
March 1 2009
Last Update
November 2 2009
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115