A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma
35 Years
N/A
Both
Lymphoma, Hodgkin's Disease, Non-Hodgkin's Lymphoma
Trial Information
A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma
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 will be administered 30-60 minutes prior to radiation treatment. Vital signs
will be monitored 5 minutes and 15 minutes after amifostine injection as well as immediately
following radiation treatment.
Patients will also complete a quality-of-life questionnaire on the first and last day of
radiation treatment. Follow-up questionnaires will be done at follow-up visits 1 month, 3
months, 6 months, 12 months, 18 months and 24 months after completion of radiation therapy.
Patients will be removed from the study if they develop an allergic reaction to amifostine.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Andrea K. Ng, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
02-292
NCT ID:
NCT00136474
Start Date:
May 2003
Completion Date:
March 2009
Related Keywords:
- Lymphoma
- Hodgkin's Disease
- Non-Hodgkin's Lymphoma
- Lymphoma
- Radiation therapy
- Amifostine
- Hodgkin Disease
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
