Trial record 6 of 1191 for:    "Hodgkin lymphoma"

Proton Therapy for Hodgkin Lymphoma (HL01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00850200
Recruitment Status : Completed
First Posted : February 24, 2009
Results First Posted : March 21, 2014
Last Update Posted : February 22, 2018
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

  Participant Flow

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
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
Withdrawal by Subject                1 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      5  26.3% 
Between 18 and 65 years      14  73.7% 
>=65 years      0   0.0% 
[Units: Years]
Median (Full Range)
 (7.7 to 57.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      14  73.7% 
Male      5  26.3% 
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.  

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.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
No text entered.

  More Information

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

IRB #70-2003: Radiation Oncology Outcome Tracking Project (RADTRAC); PI: Robert J. Amdur.

Responsible Party: University of Florida 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