Proton Radiation for Lymphoma Involving Mediastinum

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.

Study Overview

• Status: Terminated
• Conditions: Lymphoma
• Intervention / Treatment: Radiation: Proton Radiation

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).

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proton Radiation; Delivered daily (Monday-Friday) for two to five weeks.	Radiation: Proton Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Radiation Dose to Normal Heart Tissue	The mean radiation dose to the heart in Gy RBE (Gray relative biological effectiveness).	6 weeks
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.	6 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
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.	90 Days
Late Toxicities	Late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers.	5 years
6-Month Overall Survival	The number of participants surviving six months after starting treatment	6 Months
6-Month Progression-Free Survival	The number of participants surviving without disease progression six months after the start of treatment	6 Months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Thomas DeLaney, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: December 14, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 18, 2012

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Non-Hodgkin Lymphoma; Hodgkin; Mediastinal; Adult Lymphoma; Pediatric Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: 12-346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO