Proton Radiation for Lymphoma Involving Mediastinum
This research study is a Pilot Study. Pilot studies are conducted to see if it is practical to do this type of research on a larger scale in the future. The pilot part of this study is to assess the possibility of using proton radiation to treat lymphomas. Proton radiation is used for many other types of malignancies, but its use for the treatment of lymphoma has been limited. The treatment is still being studied as research doctors are trying to find out more about its use in the treatment of different types of lymphoma. Proton beam radiation therapy is an FDA approved radiation delivery system.
Patients are being asked to participate in this research study if they have lymphoma in the center of their chest, near their heart. Conventional radiation therapy with photons is used as standard treatment for many patients with lymphoma. In this research study investigators are looking at another type of radiation called proton radiation, which is known to spare surrounding tissue and organs from radiation. Proton radiation delivers radiation to the area requiring radiation but delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy.
In this research study, investigators are evaluating the effectiveness of using proton radiation delivered to reduce side effects associated with radiation treatment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study Evaluating the Use of Proton Radiation for Treatment of Lymphoma Involving the Mediastinum|
- Radiation dose to normal tissue [ Time Frame: 2 years ] [ Designated as safety issue: No ]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
- Disease specific outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate disease specific outcomes including progression free survival, local control and overall survival
- Acute toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To assess acute toxicities including pericarditis, pneumonitis, Lhermitte's, dermatitis, mucositis, esophagitis, leukopenia, xerostomia, and thrombocytopenia
- Late toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To evaluate late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2020|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Proton Radiation
Delivered daily (Monday-Friday) for two to five weeks.
|Radiation: Proton Radiation|
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 markers.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751412
|Contact: Karen Winkfield, MD, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Karen Winkfield, MD, PhD 617-724-2340 email@example.com|
|Principal Investigator: Karen Winkfield, MD, PhD|
|Principal Investigator:||Karen Winkfield, MD, PhD||Massachusetts General Hospital|