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
  Purpose

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.


Condition Intervention Phase
Hodgkin Lymphoma
Radiation: Proton Radiation Plan
Radiation: Conventional Photon Radiation Plan
Radiation: Intensity Modulated Radiation Plan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: August 2009
Estimated Study Completion Date: July 2020
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Radiation Plan Radiation: Proton Radiation Plan
Between 21-39.6 Gy/CGE to the PTV
Active Comparator: Conventional Photon Radiation Plan Radiation: Conventional Photon Radiation Plan
Between 21-39.6 Gy/CGE to the PTV
Active Comparator: Intensity Modulated Radiation Plan Radiation: Intensity Modulated Radiation Plan
Between 21-39.6 Gy/CGE to the PTV

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)

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior radiotherapy.
  • Prior or concurrent cancer other than non-melanomatous skin cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850200

Locations
United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Bradford S Hoppe, MD, MPH University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:
Constine LS, Tarbell N, Hudson MM, et al. Subsequent malignancies in children treated for Hodgkin's disease: associations with gender and radiation dose. Int J Radiat Oncol Biol Phys 2008;72:24-33.
Campbell BA, Voss N, Pickles T, et al. Involved-nodal radiation therapy as a component of combination therapy for limited-stage Hodgkin's lymphoma: a question of field size. J Clin Oncol 2008;26:5170-5174.
Goodman KA, Toner S, Hunt M, et al. Intensity-modulated radiotherapy for lymphoma involving the mediastinum. Int J Radiat Oncol Biol Phys 2005;62:198-206.
Hernando ML, Marks LB, Bentel GC, et al. Radiation-induced pulmonary toxicity: a dose-volume histogram analysis in 201 patients with lung cancer. Int J Radiat Oncol Biol Phys 2001;51:650-659.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00850200     History of Changes
Other Study ID Numbers: UFPTI 0806 - HL01
Study First Received: February 20, 2009
Results First Received: December 13, 2013
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Hodgkin Lymphoma, Proton Radiation

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014