Proton Radiation for Lymphoma Involving Mediastinum

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01751412
• Other study ID #: 12-346
• Status: Terminated
• Phase: N/A
• First received: December 14, 2012
• Last updated: October 20, 2017
• Start date: February 2013
• Est. completion date: February 2017

Study information

• Verified date: October 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Radiation:
• Proton Radiation

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Radiation Dose to Normal Heart Tissue	The mean radiation dose to the heart in Gy RBE (Gray relative biological effectiveness).	6 weeks
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.	6 Weeks
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.	2 years
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.	90 Days
Secondary	Late Toxicities	Late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers.	5 years
Secondary	6-Month Overall Survival	The number of participants surviving six months after starting treatment	6 Months
Secondary	6-Month Progression-Free Survival	The number of participants surviving without disease progression six months after the start of treatment	6 Months