Proton Radiation for Lymphoma Involving Mediastinum
| Status: | Terminated |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 6 - Any |
| Updated: | 11/25/2017 |
| Start Date: | February 2013 |
| End Date: | February 2017 |
Pilot Study Evaluating the Use of Proton Radiation for Treatment of Lymphoma Involving the 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.
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.
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).
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).
Inclusion Criteria:
- Histologically confirmed Hodgkin lymphoma or non-Hodgkin lymphoma
- Must complete standard chemotherapy appropriate for the histologic subtype of lymphoma
and be able to start radiation therapy within 3-6 weeks of completing chemotherapy
- Life expectancy of at least 12 months
- Must have achieved complete or partial response per appropriate imaging technique
within 4 weeks of study entry following administration of chemotherapy
- Individuals with known history of HIV positivity must be on appropriate HAART therapy
Exclusion Criteria:
- Pregnant or breastfeeding
- Prior therapeutic radiation therapy > 200 cGy has been delivered to target volume
- Have not recovered from adverse events due to systemic agents administered more than 4
weeks earlier
- Uncontrolled intercurrent illness
- History of a different malignancy unless disease free for at least 2 years (cervical
cancer in situ, basal or squamous cell carcinoma are acceptable)
- Receiving any other investigational agents
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Karen Winkfield, MD, PhD
Phone: 617-724-2340
Click here to add this to my saved trials
