Proton Therapy for Hodgkin Lymphoma (HL01)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00850200
First received: February 20, 2009
Last updated: February 4, 2014
Last verified: February 2014

February 20, 2009
February 4, 2014
August 2009
May 2013   (final data collection date for primary outcome 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 ] [ Designated as safety issue: Yes ]
To assess the reduction of normal tissue exposed to greater than or equal to 4 Gy/CGE with use of proton therapy compared to photon therapy. [ Time Frame: Prior to starting radiation therapy. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00850200 on ClinicalTrials.gov Archive Site
  • Assess Improvement and Other Dosimetric Endpoints [ Time Frame: Prior to starting radiation therapy ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Assess improvement and other dosemetric endpoints [ Time Frame: Prior to radiation therapy ] [ Designated as safety issue: No ]
  • Collect and analyze morbidity outcomes [ Time Frame: During radiation therapy, every 3 months for the first year, then every 6 months for the next 4 years, then annually ] [ Designated as safety issue: No ]
  • Assess disease control and survival outcomes [ Time Frame: During radiation therapy, every 3 months for the first year, then every 6 months for the next 4 years, then annually ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Proton Therapy for Hodgkin Lymphoma
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

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.

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)

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin Lymphoma
  • Radiation: Proton Radiation Plan
    Between 21-39.6 Gy/CGE to the PTV
  • Radiation: Conventional Photon Radiation Plan
    Between 21-39.6 Gy/CGE to the PTV
  • Radiation: Intensity Modulated Radiation Plan
    Between 21-39.6 Gy/CGE to the PTV
  • Experimental: Proton Radiation Plan
    Intervention: Radiation: Proton Radiation Plan
  • Active Comparator: Conventional Photon Radiation Plan
    Intervention: Radiation: Conventional Photon Radiation Plan
  • Active Comparator: Intensity Modulated Radiation Plan
    Intervention: Radiation: Intensity Modulated Radiation Plan

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
July 2020
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior radiotherapy.
  • Prior or concurrent cancer other than non-melanomatous skin cancer.
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00850200
UFPTI 0806 - HL01
Yes
University of Florida
University of Florida
Not Provided
Principal Investigator: Bradford S Hoppe, MD, MPH University of Florida Proton Therapy Institute
University of Florida
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP