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Proton Therapy for Hodgkin Lymphoma (HL01)

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ClinicalTrials.gov Identifier: NCT00850200
Recruitment Status : Completed
First Posted : February 24, 2009
Results First Posted : March 21, 2014
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hodgkin Lymphoma
Interventions Radiation: Proton Radiation Plan
Radiation: Conventional Photon Radiation Plan
Radiation: Intensity Modulated Radiation Plan
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Optimal Treatment Plan
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 20
Completed 19
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Proton Therapy Plan Compared to IMRT and Conventional RT
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
20 patients were enrolled. One decided to withdrawal after being enrolled, but prior to any treatment plans being performed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
5
  26.3%
Between 18 and 65 years
14
  73.7%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
24.5
(7.7 to 57.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
14
  73.7%
Male
5
  26.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Immediately proceeding completion of each of the three treatment plans
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proton Radiation Plan Conventional Photon Radiation Plan Intensity Modulated Radiation Plan
Hide Arm/Group Description:
Proton Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
Conventional Photon Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
Intensity Modulated Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
Overall Number of Participants Analyzed 19 19 19
Median (Full Range)
Unit of Measure: percentage of body receiving 4 Gy
0.161
(0.062 to 0.346)
0.291
(0.162 to 0.497)
0.355
(0.189 to 0.811)
2.Secondary Outcome
Title Assess Improvement and Other Dosimetric Endpoints
Hide Description [Not Specified]
Time Frame Prior to starting radiation therapy
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Assess Disease Control and Survival Outcomes
Hide Description [Not Specified]
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
Outcome Measure Data Not Reported
Time Frame Cumulative adverse events were collected via regular 6 month patient follow-ups after the completion of treatment.
Adverse Event Reporting Description There were 20 patients initially enrolled. One decided to not receive treatment after initial enrollment. Three had treatment plans completed (and thus contributed that data), but sought treatment elsewhere. One patient was withdrawn after treatment. There are therefore only 15 of 20 enrolled patients actually assessable for adverse events.
 
Arm/Group Title Superior Treatment Plan
Hide Arm/Group Description

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.

All-Cause Mortality
Superior Treatment Plan
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Superior Treatment Plan
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Superior Treatment Plan
Affected / at Risk (%) # Events
Total   6/15 (40.00%)    
Endocrine disorders   
thyroid problem - grade 2  1  1/15 (6.67%)  1
Gastrointestinal disorders   
Dyspepsia - acute grade 2  1  3/15 (20.00%)  3
Esophagitis - acute grade 2  1  3/15 (20.00%)  3
Skin and subcutaneous tissue disorders   
Skin toxicity - grade 2  1  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
Publications:
IRB #70-2003: Radiation Oncology Outcome Tracking Project (RADTRAC); PI: Robert J. Amdur.
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00850200     History of Changes
Other Study ID Numbers: UFPTI 0806 - HL01
First Submitted: February 20, 2009
First Posted: February 24, 2009
Results First Submitted: December 13, 2013
Results First Posted: March 21, 2014
Last Update Posted: February 22, 2018