Proton Therapy for Hodgkin Lymphoma

NCT ID: NCT00850200

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2018-01-09

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)

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Proton Radiation Plan

Group Type: EXPERIMENTAL

Proton Radiation Plan

Intervention Type: RADIATION

Between 21-39.6 Gy/CGE to the PTV

Conventional Photon Radiation Plan

Group Type: ACTIVE_COMPARATOR

Conventional Photon Radiation Plan

Intervention Type: RADIATION

Between 21-39.6 Gy/CGE to the PTV

Intensity Modulated Radiation Plan

Group Type: ACTIVE_COMPARATOR

Intensity Modulated Radiation Plan

Intervention Type: RADIATION

Between 21-39.6 Gy/CGE to the PTV

Interventions

Proton Radiation Plan

Between 21-39.6 Gy/CGE to the PTV

Intervention Type: RADIATION

Conventional Photon Radiation Plan

Between 21-39.6 Gy/CGE to the PTV

Intervention Type: RADIATION

Intensity Modulated Radiation Plan

Between 21-39.6 Gy/CGE to the PTV

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradford S Hoppe, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Florida Proton Therapy Institute

Locations

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Countries

United States

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

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Other Identifiers

UFPTI 0806 - HL01

Identifier Type: -

Identifier Source: org_study_id