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Completed

NCT Number: NCT00850200

Proton Therapy for Hodgkin Lymphoma

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.

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Proton Radiation Plan

Radiation

Between 21-39.6 Gy/CGE to the PTV

Conventional Photon Radiation Plan

Radiation

Between 21-39.6 Gy/CGE to the PTV

Intensity Modulated Radiation Plan

Radiation

Between 21-39.6 Gy/CGE to the PTV

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study 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

Acronym: HL01

Important dates

Study start
2009
Primary completion
2013
Study completion
2018
First posted
Feb 24, 2009
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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