Proton Radiation for Lymphoma Involving Mediastinum

NCT01751412 | Terminated Results DMC

• 1 other identifier: 12-346
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Local Control

  2 years

• Number of Participants With Acute Toxicities

  90 Days

• Late Toxicities

  5 years

• 6-Month Overall Survival

  6 Months

• 6-Month Progression-Free Survival

  6 Months

Study Arms (1)

Proton Radiation

EXPERIMENTAL

Delivered daily (Monday-Friday) for two to five weeks.

Radiation: Proton Radiation

Interventions

Proton Radiation RADIATION

Proton Radiation

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Limitations and Caveats

The study was terminated prematurely due to funding issues. Limited enrollment and shorter than planned follow-up prevented statistically significant evaluation of endpoints.

Results Point of Contact

• Title: Thomas F. DeLaney, MD
• Organization: Massachusetts General Hospital

TDELANEY@mgh.harvard.edu

617-726-6876

Study Officials

• Thomas DeLaney, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Francis H. Burr Proton Therapy Center

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 18, 2012
• Study Start: February 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: February 1, 2017
• Last Updated: November 24, 2017
• Results First Posted: October 17, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)