Proton Therapy for Hodgkin Lymphoma

Not Applicable

Completed

• Conditions: Hodgkin Lymphoma
• Interventions: Radiation: Conventional Photon Radiation Plan; Radiation: Intensity Modulated Radiation Plan; Radiation: Proton Radiation Plan

• Registration Number: NCT00850200
• Lead Sponsor: 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.

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)

Study Timeline

• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-24
• Study Start: 2009-08
• Primary Completion: 2013-05
• Results First Submitted: 2013-12-13
• Results First Submitted QC: 2014-02-04
• Results First Posted: 2014-03-21
• Study Completion: 2018-01-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conventional Photon Radiation Plan	Conventional Photon Radiation Plan	-
Intensity Modulated Radiation Plan	Intensity Modulated Radiation Plan	-
Proton Radiation Plan	Proton Radiation Plan	-

Primary Outcome Measures

Name	Time	Method
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.	Immediately proceeding completion of each of the three treatment plans

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Survived	4 years after beginning of radiation therapy	Overall survival as assessed with the Kaplan-Meier product limit method.
Percentage of Participants Who Did Not Have Disease Progression	4 years after beginning of radiation therapy	Disease free survival as assessed with the Kaplan-Meier product limit method

Trial Locations

Locations (1)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States