Proton Therapy for Hodgkin Lymphoma

Study 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). 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)

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

Conditions
-----------------
Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Radiation: Proton Radiation Plan
* Radiation: Conventional Photon Radiation Plan
* Radiation: Intensity Modulated Radiation Plan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed classic Hodgkin lymphoma. Completed chemotherapy. Exclusion Criteria: Prior radiotherapy. Prior or concurrent cancer other than non-melanomatous skin cancer.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton Radiation Plan<br> | Radiation: Proton Radiation Plan<br>* Between 21-39.6 Gy/CGE to the PTV<br>|
| Active Comparator: Conventional Photon Radiation Plan<br> | Radiation: Conventional Photon Radiation Plan<br>* Between 21-39.6 Gy/CGE to the PTV<br>|
| Active Comparator: Intensity Modulated Radiation Plan<br> | Radiation: Intensity Modulated Radiation Plan<br>* Between 21-39.6 Gy/CGE to the PTV<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Immediately proceeding completion of each of the three treatment plans | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Survived | Overall survival as assessed with the Kaplan-Meier product limit method. | 4 years after beginning of radiation therapy | 
| Percentage of Participants Who Did Not Have Disease Progression | Disease free survival as assessed with the Kaplan-Meier product limit method | 4 years after beginning of radiation therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hodgkin Lymphoma, Proton Radiation