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Proton Radiation for Lymphoma Involving Mediastinum

Pilot Study Evaluating the Use of Proton Radiation for Treatment of Lymphoma Involving the Mediastinum

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01751412
Enrollment
12
Registered
2012-12-18
Start date
2013-02-28
Completion date
2017-02-28
Last updated
2017-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

Hodgkin, Non-Hodgkin Lymphoma, Mediastinal, Adult Lymphoma, Pediatric Lymphoma

Brief summary

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.

Detailed description

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).

Interventions

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Radiation Dose to Normal Heart Tissue6 weeksThe mean radiation dose to the heart in Gy RBE (Gray relative biological effectiveness).
Radiation Dose to the Normal Tissue of the Lungs6 WeeksThe percentage of the lung volume which received radiation dose of 20 Gray (Gy) or more. The lung volume percentages for the 12 participants were averaged and presented separately for the left and right lungs.

Secondary

MeasureTime frameDescription
Late Toxicities5 yearsLate toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers.
Local Control2 yearsThe number of participants who maintained local control for the duration of their followup. Local control is defined as the lack of disease progression. Progression is the increased growth of cancer cells or the spread of the cancer cells to another location within the body.
6-Month Progression-Free Survival6 MonthsThe number of participants surviving without disease progression six months after the start of treatment
6-Month Overall Survival6 MonthsThe number of participants surviving six months after starting treatment
Number of Participants With Acute Toxicities90 DaysAcute toxicities including pericarditis, pneumonitis, Lhermitte's, dermatitis, mucositis, esophagitis, leukopenia, xerostomia, and thrombocytopenia. Data is shown as the number of participants that experienced the given toxicities.

Countries

United States

Participant flow

Participants by arm

ArmCount
Proton Radiation
Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
12
Total12

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDisease Progression Before Treatment1

Baseline characteristics

CharacteristicProton Radiation
Age, Categorical
<=18 years
1 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
Age, Continuous28 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
12 Participants
Region of Enrollment
United States
12 participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 11
other
Total, other adverse events
9 / 11
serious
Total, serious adverse events
0 / 11

Outcome results

Primary

Mean Radiation Dose to Normal Heart Tissue

The mean radiation dose to the heart in Gy RBE (Gray relative biological effectiveness).

Time frame: 6 weeks

ArmMeasureValue (MEAN)
Proton RadiationMean Radiation Dose to Normal Heart Tissue5.4 Gy(RBE)
Primary

Radiation Dose to the Normal Tissue of the Lungs

The percentage of the lung volume which received radiation dose of 20 Gray (Gy) or more. The lung volume percentages for the 12 participants were averaged and presented separately for the left and right lungs.

Time frame: 6 Weeks

ArmMeasureGroupValue (MEAN)
Proton RadiationRadiation Dose to the Normal Tissue of the LungsLeft Lung9.17 Percentage of Lung Volume
Proton RadiationRadiation Dose to the Normal Tissue of the LungsRight Lung8.79 Percentage of Lung Volume
Secondary

6-Month Overall Survival

The number of participants surviving six months after starting treatment

Time frame: 6 Months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Proton Radiation6-Month Overall Survival12 Participants
Secondary

6-Month Progression-Free Survival

The number of participants surviving without disease progression six months after the start of treatment

Time frame: 6 Months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Proton Radiation6-Month Progression-Free Survival12 Participants
Secondary

Late Toxicities

Late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers.

Time frame: 5 years

Population: The trial was terminated before the study endpoint was met. The data is not available for analysis.

Secondary

Local Control

The number of participants who maintained local control for the duration of their followup. Local control is defined as the lack of disease progression. Progression is the increased growth of cancer cells or the spread of the cancer cells to another location within the body.

Time frame: 2 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Proton RadiationLocal Control10 Participants
Secondary

Number of Participants With Acute Toxicities

Acute toxicities including pericarditis, pneumonitis, Lhermitte's, dermatitis, mucositis, esophagitis, leukopenia, xerostomia, and thrombocytopenia. Data is shown as the number of participants that experienced the given toxicities.

Time frame: 90 Days

ArmMeasureGroupValue (NUMBER)
Proton RadiationNumber of Participants With Acute Toxicitiespericarditis0 participants
Proton RadiationNumber of Participants With Acute Toxicitiespneumonitis0 participants
Proton RadiationNumber of Participants With Acute ToxicitiesLhermitte's0 participants
Proton RadiationNumber of Participants With Acute Toxicitiesdermatitis9 participants
Proton RadiationNumber of Participants With Acute Toxicitiesmucositis0 participants
Proton RadiationNumber of Participants With Acute Toxicitiesesophagitis2 participants
Proton RadiationNumber of Participants With Acute Toxicitiesleukopenia0 participants
Proton RadiationNumber of Participants With Acute Toxicitiesxerostomia0 participants
Proton RadiationNumber of Participants With Acute Toxicitiesthrombocytopenia0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026