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: September 11, 2014
Last verified: September 2014
Results First Received: December 13, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hodgkin Lymphoma
Interventions: Radiation: Proton Radiation Plan
Radiation: Conventional Photon Radiation Plan
Radiation: Intensity Modulated Radiation Plan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Optimal Treatment Plan

Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).

The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm.


Participant Flow:   Overall Study
    Optimal Treatment Plan  
STARTED     20  
COMPLETED     19  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
20 patients were enrolled. One decided to withdrawal after being enrolled, but prior to any treatment plans being performed.

Reporting Groups
  Description
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).

Baseline Measures
    Proton Therapy Plan Compared to IMRT and Conventional RT  
Number of Participants  
[units: participants]
  19  
Age  
[units: participants]
 
<=18 years     5  
Between 18 and 65 years     14  
>=65 years     0  
Age  
[units: years]
Median ( Full Range )
  24.5  
  ( 7.7 to 57.6 )  
Gender  
[units: participants]
 
Female     14  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     19  



  Outcome Measures

1.  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 ]

2.  Secondary:   Assess Improvement and Other Dosimetric Endpoints   [ Time Frame: Prior to starting radiation therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Bradford Hoppe, MD, MPH
Organization: University of Florida Proton Therapy Institute
phone: 904-588-1800
e-mail: bhoppe@floridaproton.org


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: September 11, 2014
Health Authority: United States: Institutional Review Board