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Proton Radiation for Lymphoma Involving Mediastinum

This study has been terminated.
(Slow accrual rates/ lack of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751412
First Posted: December 18, 2012
Last Update Posted: November 24, 2017
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.
Information provided by (Responsible Party):
Tom DeLaney, MD, Massachusetts General Hospital
Results First Submitted: September 15, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma
Intervention: Radiation: Proton Radiation

  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
Proton Radiation Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.

Participant Flow:   Overall Study
    Proton Radiation
STARTED   12 
COMPLETED   11 
NOT COMPLETED   1 
Disease Progression Before Treatment                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.
No text entered.

Reporting Groups
  Description
Proton Radiation Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.

Baseline Measures
   Proton Radiation 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      1   8.3% 
Between 18 and 65 years      11  91.7% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 28 
 (17 to 61) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  83.3% 
Male      2  16.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      11  91.7% 
Unknown or Not Reported      1   8.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      12 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Radiation Dose to Normal Heart Tissue   [ Time Frame: 6 weeks ]

2.  Primary:   Radiation Dose to the Normal Tissue of the Lungs   [ Time Frame: 6 Weeks ]

3.  Secondary:   Local Control   [ Time Frame: 2 years ]

4.  Secondary:   Number of Participants With Acute Toxicities   [ Time Frame: 90 Days ]

5.  Secondary:   Late Toxicities   [ Time Frame: 5 years ]

6.  Secondary:   6-Month Overall Survival   [ Time Frame: 6 Months ]

7.  Secondary:   6-Month Progression-Free Survival   [ Time Frame: 6 Months ]


  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
The study was terminated prematurely due to funding issues. Limited enrollment and shorter than planned follow-up prevented statistically significant evaluation of endpoints.


  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: Thomas F. DeLaney, MD
Organization: Massachusetts General Hospital
phone: 617-726-6876
e-mail: TDELANEY@mgh.harvard.edu



Responsible Party: Tom DeLaney, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01751412     History of Changes
Other Study ID Numbers: 12-346
First Submitted: December 14, 2012
First Posted: December 18, 2012
Results First Submitted: September 15, 2017
Results First Posted: October 17, 2017
Last Update Posted: November 24, 2017