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Proton Radiation for Lymphoma Involving Mediastinum

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Karen Winkfield, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01751412
First received: December 14, 2012
Last updated: June 7, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Lymphoma
Radiation: Proton Radiation
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study Evaluating the Use of Proton Radiation for Treatment of Lymphoma Involving the Mediastinum

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Radiation dose to normal tissue [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess if the treatment plans for proton therapy show an improvement in radiation dose to normal heart and lung tissue compared to conventional 3D photon plans


Secondary Outcome Measures:
  • Disease specific outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate disease specific outcomes including progression free survival, local control and overall survival

  • Acute toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To assess acute toxicities including pericarditis, pneumonitis, Lhermitte's, dermatitis, mucositis, esophagitis, leukopenia, xerostomia, and thrombocytopenia

  • Late toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To evaluate late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers


Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Radiation
Delivered daily (Monday-Friday) for two to five weeks.
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).

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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 PET-CT 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751412

Contacts
Contact: Karen Winkfield, MD, PhD 6177242340 kwinkfield@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Karen Winkfield, MD, PhD    617-724-2340    kwinkfield@partners.org   
Principal Investigator: Karen Winkfield, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Karen Winkfield, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Karen Winkfield, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01751412     History of Changes
Other Study ID Numbers: 12-346
Study First Received: December 14, 2012
Last Updated: June 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on September 16, 2014