Proton Therapy for Hodgkin Lymphoma
This trial is active, not recruiting.
|Treatments||proton radiation plan, conventional photon radiation plan, intensity modulated radiation plan|
|Sponsor||University of Florida|
|Start date||August 2009|
|End date||May 2013|
|Trial size||20 participants|
|Trial identifier||NCT00850200, UFPTI 0806 - HL01|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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
Assess Improvement and Other Dosimetric Endpoints
time frame: Prior to starting radiation therapy
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
Male or female participants at least 6 years old.
Inclusion Criteria: - Confirmed "classic" Hodgkin lymphoma. - Completed chemotherapy. Exclusion Criteria: - Prior radiotherapy. - Prior or concurrent cancer other than non-melanomatous skin cancer.
|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|
|Principal investigator||Bradford S Hoppe, MD, MPH|
|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)|
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