Hodgkin Lymphoma
Conditions
Keywords
Hodgkin Lymphoma, Proton Radiation
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)
Interventions
RADIATIONProton Radiation Plan
Between 21-39.6 Gy/CGE to the PTV
RADIATIONConventional Photon Radiation Plan
Between 21-39.6 Gy/CGE to the PTV
RADIATIONIntensity Modulated Radiation Plan
Between 21-39.6 Gy/CGE to the PTV
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed classic Hodgkin lymphoma. * Completed chemotherapy.
Exclusion criteria
* Prior radiotherapy. * Prior or concurrent cancer other than non-melanomatous skin cancer.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Survived | 4 years after beginning of radiation therapy | Overall survival as assessed with the Kaplan-Meier product limit method. |
| Percentage of Participants Who Did Not Have Disease Progression | 4 years after beginning of radiation therapy | Disease free survival as assessed with the Kaplan-Meier product limit method |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Proton Therapy Plan Compared to IMRT and Conventional RT Each patient has a proton, IMRT and conventional plan done prior to treatment for dosimetric comparison of the primary endpoint which is the percent of the body that receives 4 Gray (%V4). The plan that delivers the smallest %V4 will be the plan that is pursued for actual treatment. Therefore, each patient will have three treatment plans, but will only be treated with one of these three plans (the superior one). | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not recieve treatment | 2 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Proton Therapy Plan Compared to IMRT and Conventional RT |
|---|---|
| Age, Categorical <=18 years | 5 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 24.5 years FULL_RANGE 13.5 |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 15 |
| other Total, other adverse events | 6 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Proton Radiation Plan | 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. | 0.161 percentage of body receiving 4 Gy |
| Conventional Photon Radiation Plan | 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. | 0.291 percentage of body receiving 4 Gy |
| Intensity Modulated Radiation Plan | 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. | 0.355 percentage of body receiving 4 Gy |
Secondary
Percentage of Participants Who Did Not Have Disease Progression
Disease free survival as assessed with the Kaplan-Meier product limit method
Time frame: 4 years after beginning of radiation therapy
Population: Patients treated with the optimal dosimetric modality
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Proton Radiation Plan | Percentage of Participants Who Did Not Have Disease Progression | 93 percentage of participants |
Secondary
Percentage of Participants Who Survived
Overall survival as assessed with the Kaplan-Meier product limit method.
Time frame: 4 years after beginning of radiation therapy
Population: Patients treated with the optimal dosimetric modality
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Proton Radiation Plan | Percentage of Participants Who Survived | 92 percentage of participants |