Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2003-05-31
2009-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Radiation Post-CAR T in Refractory Lymphoma
NCT04473937
Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma
NCT00039195
Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma
NCT00446095
A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma
NCT05574114
Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment
NCT00324467
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Amifostine plus radiation therapy
Amifostine
Given 30-60 minutes prior to daily radiation therapy
Radiation Therapy
Daily radiation therapy
Group 2
Radiation therapy alone
Radiation Therapy
Daily radiation therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amifostine
Given 30-60 minutes prior to daily radiation therapy
Radiation Therapy
Daily radiation therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
35 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brigham and Women's Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
MedImmune LLC
INDUSTRY
Dana-Farber Cancer Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dana-Farber Cancer Institute/Brigham and Women's Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrea K. Ng, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
02-292
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.