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Proton Therapy for Hodgkin Lymphoma (HL01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00850200
Recruitment Status : Completed
First Posted : February 24, 2009
Results First Posted : March 21, 2014
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The purpose of this study is to reduce the risk of radiation related side effects and complications by treating with radiation (protons or photons) that exposes less of normal organs to low dose radiation.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Radiation: Proton Radiation Plan Radiation: Conventional Photon Radiation Plan Radiation: Intensity Modulated Radiation Plan Not Applicable

Detailed Description:

3 treatment plans will be created to deliver between a total of 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).

  1. Proton Plan
  2. Conventional Plan
  3. Intensity Modulated Radiotherapy (IMRT) Plan

The patient will then receive the radiation modality with the lowest percentage of the body receiving 4 Gy (V4Gy/CGE)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving the Therapeutic Ratio by Using Proton Beam Radiation Therapy for Patients With Stage IA-IIIBX (Bulky/Non-bulky) Hodgkin Lymphoma Involving the Mediastinum Following Standard Chemotherapy
Study Start Date : August 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : January 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Proton Radiation Plan Radiation: Proton Radiation Plan
Between 21-39.6 Gy/CGE to the PTV

Active Comparator: Conventional Photon Radiation Plan Radiation: Conventional Photon Radiation Plan
Between 21-39.6 Gy/CGE to the PTV

Active Comparator: Intensity Modulated Radiation Plan Radiation: Intensity Modulated Radiation Plan
Between 21-39.6 Gy/CGE to the PTV




Primary Outcome Measures :
  1. Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy. [ Time Frame: Immediately proceeding completion of each of the three treatment plans ]

Secondary Outcome Measures :
  1. Percentage of Participants Who Survived [ Time Frame: 4 years after beginning of radiation therapy ]
    Overall survival as assessed with the Kaplan-Meier product limit method.

  2. Percentage of Participants Who Did Not Have Disease Progression [ Time Frame: 4 years after beginning of radiation therapy ]
    Disease free survival as assessed with the Kaplan-Meier product limit method



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Confirmed "classic" Hodgkin lymphoma.
  • Completed chemotherapy.

Exclusion Criteria:

  • Prior radiotherapy.
  • Prior or concurrent cancer other than non-melanomatous skin cancer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850200


Locations
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United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Bradford S Hoppe, MD, MPH University of Florida Proton Therapy Institute

Additional Information:
Publications:
IRB #70-2003: Radiation Oncology Outcome Tracking Project (RADTRAC); PI: Robert J. Amdur.

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00850200     History of Changes
Other Study ID Numbers: UFPTI 0806 - HL01
First Posted: February 24, 2009    Key Record Dates
Results First Posted: March 21, 2014
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Hodgkin Lymphoma, Proton Radiation
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases