Clinical trial NCT00850200: Proton Therapy for Hodgkin Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hodgkin Lymphoma
Keywords: Hodgkin Lymphoma, Proton Radiation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: Immediately proceeding completion of each of the three treatment plans
Secondary outcomes:
measure: Percentage of Participants Who Survived
timeFrame: 4 years after beginning of radiation therapy
measure: Percentage of Participants Who Did Not Have Disease Progression
timeFrame: 4 years after beginning of radiation therapy
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Bradford S Hoppe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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