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Proton Therapy for Hodgkin Lymphoma (HL01)

Primary Purpose

Hodgkin Lymphoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Radiation Plan
Conventional Photon Radiation Plan
Intensity Modulated Radiation Plan
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Hodgkin Lymphoma, Proton Radiation

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Florida Proton Therapy Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Proton Radiation Plan

Conventional Photon Radiation Plan

Intensity Modulated Radiation Plan

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Who Survived
Overall survival as assessed with the Kaplan-Meier product limit method.
Percentage of Participants Who Did Not Have Disease Progression
Disease free survival as assessed with the Kaplan-Meier product limit method

Full Information

First Posted
February 20, 2009
Last Updated
January 8, 2019
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00850200
Brief Title
Proton Therapy for Hodgkin Lymphoma
Acronym
HL01
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 Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
January 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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). Proton Plan Conventional Plan 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
Hodgkin Lymphoma, Proton Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proton Radiation Plan
Arm Type
Experimental
Arm Title
Conventional Photon Radiation Plan
Arm Type
Active Comparator
Arm Title
Intensity Modulated Radiation Plan
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
Proton Radiation Plan
Intervention Description
Between 21-39.6 Gy/CGE to the PTV
Intervention Type
Radiation
Intervention Name(s)
Conventional Photon Radiation Plan
Intervention Description
Between 21-39.6 Gy/CGE to the PTV
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated Radiation Plan
Intervention Description
Between 21-39.6 Gy/CGE to the PTV
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Percentage of Participants Who Survived
Description
Overall survival as assessed with the Kaplan-Meier product limit method.
Time Frame
4 years after beginning of radiation therapy
Title
Percentage of Participants Who Did Not Have Disease Progression
Description
Disease free survival as assessed with the Kaplan-Meier product limit method
Time Frame
4 years after beginning of radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed "classic" Hodgkin lymphoma. Completed chemotherapy. Exclusion Criteria: Prior radiotherapy. Prior or concurrent cancer other than non-melanomatous skin cancer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradford S Hoppe, MD, MPH
Organizational Affiliation
University of Florida Proton Therapy Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States

12. IPD Sharing Statement

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Proton Therapy for Hodgkin Lymphoma

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