Pilot Study Evaluating the Use of Proton Radiation for Treatment of Lymphoma Involving the Mediastinum
If a person agrees to participate in this research study, they will be asked to undergo some
screening tests or procedures to confirm eligibility. Many of these tests and procedures are
likely to be part of regular cancer care and may be done even if it turns out that a patient
does not take part in the research study. If a patient has had some of these tests or
procedures recently, they may or may not have to be repeated. These tests and procedures
include: a medical history, performance status, physical examination, assessment of tumor,
echocardiogram, electrocardiogram, pulmonary (lung) function tests and blood tests. If these
tests show that a patient is eligible to participate in the research study, they will begin
the study treatment. If a patient does not meet the eligibility criteria, they will not be
able to participate in the research study.
Proton radiation will be delivered daily for 2 to 5 weeks, depending on the dose prescribed
by your physician. Treatment is delivered (Monday-Friday) for 5 days (no weekends or
holidays). Each treatment will require that you lie on a table for 30 to 45 minutes.
Participants will receive radiation therapy as an outpatient at Massachusetts General
Hospital. During radiation therapy, they will have the following weekly assessments and
procedures: physical exam, assess for any side effects, blood tests for cardiac markers.
Study participants will be asked to return for a follow up visit 6-12 weeks after their last
dose of radiation therapy. During this visit the following tests and procedures will be
done: PET/CT scan, physical exam, assess for side effects and blood tests for cardiac
Participants will also be asked to return for a follow-up visit at 6 months, 12 months and
annually for five years post radiation. Keeping in touch with study participants and
checking on their condition helps investigators look at the long-term effects of the
research study. At these visits, the following tests and procedures will be done: physical
exam, assess for any side effects, ECG, ECHO, pulmonary tests, PET/CT scan, routine blood
tests and blood tests for cardiac markers (at 6 months and 1 years only).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Radiation dose to normal tissue
To assess if the treatment plans for proton therapy show an improvement in radiation dose to normal heart and lung tissue compared to conventional 3D photon plans
Karen Winkfield, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|