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Proton Radiation for Lymphoma Involving Mediastinum

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ClinicalTrials.gov Identifier: NCT01751412
Recruitment Status : Terminated (Slow accrual rates/ lack of funding)
First Posted : December 18, 2012
Results First Posted : October 17, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Tom DeLaney, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Intervention Radiation: Proton Radiation
Enrollment 12

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Proton Radiation
Hide Arm/Group Description Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Period Title: Overall Study
Started 12
Completed 11
Not Completed 1
Reason Not Completed
Disease Progression Before Treatment             1
Arm/Group Title Proton Radiation
Hide Arm/Group Description Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
1
   8.3%
Between 18 and 65 years
11
  91.7%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
28
(17 to 61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
10
  83.3%
Male
2
  16.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
11
  91.7%
Unknown or Not Reported
1
   8.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Mean Radiation Dose to Normal Heart Tissue
Hide Description The mean radiation dose to the heart in Gy RBE (Gray relative biological effectiveness).
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proton Radiation
Hide Arm/Group Description:
Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Overall Number of Participants Analyzed 12
Mean (Full Range)
Unit of Measure: Gy(RBE)
5.4
(1.63 to 17.13)
2.Primary Outcome
Title Radiation Dose to the Normal Tissue of the Lungs
Hide Description The percentage of the lung volume which received radiation dose of 20 Gray (Gy) or more. The lung volume percentages for the 12 participants were averaged and presented separately for the left and right lungs.
Time Frame 6 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proton Radiation
Hide Arm/Group Description:
Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Overall Number of Participants Analyzed 12
Mean (Full Range)
Unit of Measure: Percentage of Lung Volume
Left Lung
9.17
(3.27 to 20.22)
Right Lung
8.79
(2.38 to 16.48)
3.Secondary Outcome
Title Local Control
Hide Description The number of participants who maintained local control for the duration of their followup. Local control is defined as the lack of disease progression. Progression is the increased growth of cancer cells or the spread of the cancer cells to another location within the body.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proton Radiation
Hide Arm/Group Description:
Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
10
  83.3%
4.Secondary Outcome
Title Number of Participants With Acute Toxicities
Hide Description Acute toxicities including pericarditis, pneumonitis, Lhermitte's, dermatitis, mucositis, esophagitis, leukopenia, xerostomia, and thrombocytopenia. Data is shown as the number of participants that experienced the given toxicities.
Time Frame 90 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proton Radiation
Hide Arm/Group Description:
Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
pericarditis 0
pneumonitis 0
Lhermitte's 0
dermatitis 9
mucositis 0
esophagitis 2
leukopenia 0
xerostomia 0
thrombocytopenia 0
5.Secondary Outcome
Title Late Toxicities
Hide Description Late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The trial was terminated before the study endpoint was met. The data is not available for analysis.
Arm/Group Title Proton Radiation
Hide Arm/Group Description:
Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title 6-Month Overall Survival
Hide Description The number of participants surviving six months after starting treatment
Time Frame 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proton Radiation
Hide Arm/Group Description:
Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
12
 100.0%
7.Secondary Outcome
Title 6-Month Progression-Free Survival
Hide Description The number of participants surviving without disease progression six months after the start of treatment
Time Frame 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proton Radiation
Hide Arm/Group Description:
Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
12
 100.0%
Time Frame Weekly during radiation therapy. After completion of therapy at 6-12 weeks , 6 months, and annually during follow-up. Patients are followed for 5 years or until death, whichever occurs first. Study was terminated before planned and participants were only followed for a median duration of 2 years.
Adverse Event Reporting Description Toxicity is evaluated with physical exams; cardiology exams (Echocardiogram and Electrocardiogram); pulmonary function tests (Diffusing capacity of the lungs for carbon monoxide (DLCO), forced exhaled volume in 1 second (FEV 1) and FEV1 / FVC (forced vital capacity); and laboratory tests.
 
Arm/Group Title Proton Radiation
Hide Arm/Group Description Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
All-Cause Mortality
Proton Radiation
Affected / at Risk (%)
Total   0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Proton Radiation
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Proton Radiation
Affected / at Risk (%) # Events
Total   9/11 (81.82%)    
Cardiac disorders   
Cardiac disorders - Other, specify  1  1/11 (9.09%)  1
Palpitations  1  1/11 (9.09%)  1
Sinus bradycardia  1  1/11 (9.09%)  1
Ear and labyrinth disorders   
Tinnitus  1  1/11 (9.09%)  1
Gastrointestinal disorders   
Constipation  1  1/11 (9.09%)  1
Dysphagia  1  2/11 (18.18%)  2
Esophageal obstruction  1  1/11 (9.09%)  1
Esophagitis  1  2/11 (18.18%)  2
Gastroesophageal reflux disease  1  3/11 (27.27%)  3
Nausea  1  2/11 (18.18%)  2
Vomiting  1  1/11 (9.09%)  1
General disorders   
Fatigue  1  6/11 (54.55%)  8
General disorders and administration site conditions - Other, specify  1  2/11 (18.18%)  2
Non-cardiac chest pain  1  1/11 (9.09%)  1
Pain  1  2/11 (18.18%)  2
Immune system disorders   
Immune system disorders - Other, specify  1  1/11 (9.09%)  1
Infections and infestations   
Upper respiratory infection  1  1/11 (9.09%)  1
Injury, poisoning and procedural complications   
Dermatitis radiation  1  9/11 (81.82%)  10
Investigations   
Forced expiratory volume decreased  1  2/11 (18.18%)  2
Weight loss  1  1/11 (9.09%)  1
Metabolism and nutrition disorders   
Anorexia  1  2/11 (18.18%)  2
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/11 (9.09%)  1
Osteoporosis  1  1/11 (9.09%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  1/11 (9.09%)  1
Nervous system disorders   
Headache  1  1/11 (9.09%)  1
Paresthesia  1  1/11 (9.09%)  1
Psychiatric disorders   
Anxiety  1  3/11 (27.27%)  3
Insomnia  1  1/11 (9.09%)  1
Reproductive system and breast disorders   
Irregular menstruation  1  1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/11 (9.09%)  1
Dyspnea  1  1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/11 (9.09%)  1
Sore throat  1  1/11 (9.09%)  2
Skin and subcutaneous tissue disorders   
Alopecia  1  3/11 (27.27%)  3
Pruritus  1  1/11 (9.09%)  1
Rash acneiform  1  1/11 (9.09%)  1
Skin hyperpigmentation  1  2/11 (18.18%)  2
Vascular disorders   
Hot flashes  1  2/11 (18.18%)  2
Hypertension  1  1/11 (9.09%)  1
Thromboembolic event  1  1/11 (9.09%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
The study was terminated prematurely due to funding issues. Limited enrollment and shorter than planned follow-up prevented statistically significant evaluation of endpoints.
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
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