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Clinical Trials/NCT00850200
NCT00850200
Completed
Not Applicable

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

University of Florida1 site in 1 country20 target enrollmentAugust 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hodgkin Lymphoma
Sponsor
University of Florida
Enrollment
20
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
7 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
January 9, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

  • Percentage of Participants Who Survived(4 years after beginning of radiation therapy)
  • Percentage of Participants Who Did Not Have Disease Progression(4 years after beginning of radiation therapy)

Study Sites (1)

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