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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 : Active, not recruiting
First Posted : February 24, 2009
Results First Posted : March 21, 2014
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Hodgkin Lymphoma Radiation: Proton Radiation Plan Radiation: Conventional Photon Radiation Plan Radiation: Intensity Modulated Radiation Plan

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 Design

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
Primary Completion Date : May 2013
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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. Assess Improvement and Other Dosimetric Endpoints [ Time Frame: Prior to starting radiation therapy ]
  2. Assess Disease Control and Survival Outcomes [ Time Frame: During radiation therapy; then after radiation, every 3 months for the first year, then every 6 months for the next 4 years, then annually ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
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.
Contacts and Locations

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

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

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: August 23, 2017
Last Verified: August 2017

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