Proton Radiation for Lymphoma Involving Mediastinum

• ClinicalTrials.gov Identifier: NCT01751412
• Recruitment Status: Terminated
• First Posted: December 18, 2012
• Results First Posted: October 17, 2017
• Last Update Posted: November 24, 2017
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Tom DeLaney, MD, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lymphoma	Radiation: Proton Radiation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study Evaluating the Use of Proton Radiation for Treatment of Lymphoma Involving the Mediastinum
• Actual Study Start Date: February 2013
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: February 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Mean Radiation Dose to Normal Heart Tissue [ Time Frame: 6 weeks ]
   The mean radiation dose to the heart in Gy RBE (Gray relative biological effectiveness).
2. Radiation Dose to the Normal Tissue of the Lungs [ Time Frame: 6 Weeks ]
   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.

Secondary Outcome Measures :

1. Local Control [ Time Frame: 2 years ]
   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. Number of Participants With Acute Toxicities [ Time Frame: 90 Days ]
   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.
3. Late Toxicities [ Time Frame: 5 years ]
   Late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers.
4. 6-Month Overall Survival [ Time Frame: 6 Months ]
   The number of participants surviving six months after starting treatment
5. 6-Month Progression-Free Survival [ Time Frame: 6 Months ]
   The number of participants surviving without disease progression six months after the start of treatment

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: Thomas DeLaney, MD; Massachusetts General Hospital

More Information

• Responsible Party: Tom DeLaney, MD, Medical Director, Francis H. Burr Proton Therapy Center, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01751412
• Other Study ID Numbers: 12-346
• First Posted: December 18, 2012
• Results First Posted: October 17, 2017
• Last Update Posted: November 24, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Tom DeLaney, MD, Massachusetts General Hospital:

Hodgkin; Non-Hodgkin Lymphoma; Mediastinal; Adult Lymphoma; Pediatric Lymphoma

Additional relevant MeSH terms:

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases