Overview

This trial is active, not recruiting.

Condition hodgkin lymphoma
Treatments proton radiation plan, conventional photon radiation plan, intensity modulated radiation plan
Phase phase 2
Sponsor University of Florida
Start date August 2009
End date May 2013
Trial size 20 participants
Trial identifier NCT00850200, UFPTI 0806 - HL01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
proton radiation plan
Between 21-39.6 Gy/CGE to the PTV
(Active Comparator)
conventional photon radiation plan
Between 21-39.6 Gy/CGE to the PTV
(Active Comparator)
intensity modulated radiation plan
Between 21-39.6 Gy/CGE to the PTV

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.
time frame: Immediately proceeding completion of each of the three treatment plans

Secondary Outcomes

Measure
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

Eligibility Criteria

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.

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by University of Florida.