Trial Outcomes & Findings for Proton Radiation for Lymphoma Involving Mediastinum (NCT NCT01751412)

NCT ID: NCT01751412

Last Updated: 2017-11-24

Results Overview

The mean radiation dose to the heart in Gy RBE (Gray relative biological effectiveness).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2017-11-24

Participant Flow

Participant milestones

Measure	Proton Radiation Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Proton Radiation Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Overall Study Disease Progression Before Treatment	1

Baseline Characteristics

Proton Radiation for Lymphoma Involving Mediastinum

Baseline characteristics by cohort

Measure	Proton Radiation n=12 Participants Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

The mean radiation dose to the heart in Gy RBE (Gray relative biological effectiveness).

Outcome measures

Measure	Proton Radiation n=12 Participants Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Mean Radiation Dose to Normal Heart Tissue	5.4 Gy(RBE) Interval 1.63 to 17.13

PRIMARY outcome

Timeframe: 6 Weeks

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.

Outcome measures

Measure	Proton Radiation n=12 Participants Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Radiation Dose to the Normal Tissue of the Lungs Left Lung	9.17 Percentage of Lung Volume Interval 3.27 to 20.22
Radiation Dose to the Normal Tissue of the Lungs Right Lung	8.79 Percentage of Lung Volume Interval 2.38 to 16.48

SECONDARY outcome

Timeframe: 2 years

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.

Outcome measures

Measure	Proton Radiation n=12 Participants Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Local Control	10 Participants

SECONDARY outcome

Timeframe: 90 Days

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.

Outcome measures

Measure	Proton Radiation n=12 Participants Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Number of Participants With Acute Toxicities dermatitis	9 participants
Number of Participants With Acute Toxicities mucositis	0 participants
Number of Participants With Acute Toxicities leukopenia	0 participants
Number of Participants With Acute Toxicities xerostomia	0 participants
Number of Participants With Acute Toxicities thrombocytopenia	0 participants
Number of Participants With Acute Toxicities esophagitis	2 participants
Number of Participants With Acute Toxicities pericarditis	0 participants
Number of Participants With Acute Toxicities pneumonitis	0 participants
Number of Participants With Acute Toxicities Lhermitte's	0 participants

SECONDARY outcome

Timeframe: 5 years

Population: The trial was terminated before the study endpoint was met. The data is not available for analysis.

Late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 Months

The number of participants surviving six months after starting treatment

Outcome measures

Measure	Proton Radiation n=12 Participants Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
6-Month Overall Survival	12 Participants

SECONDARY outcome

Timeframe: 6 Months

The number of participants surviving without disease progression six months after the start of treatment

Outcome measures

Measure	Proton Radiation n=12 Participants Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
6-Month Progression-Free Survival	12 Participants

Adverse Events

Proton Radiation

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Proton Radiation n=11 participants at risk Proton Radiation, delivered daily (Monday-Friday) for two to five weeks.
Skin and subcutaneous tissue disorders Alopecia	27.3% 3/11 • Number of events 3 • 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. 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.
Metabolism and nutrition disorders Anorexia	18.2% 2/11 • Number of events 2 • 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. 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.
Psychiatric disorders Anxiety	27.3% 3/11 • Number of events 3 • 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. 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.
Musculoskeletal and connective tissue disorders Arthritis	9.1% 1/11 • Number of events 1 • 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. 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.
Cardiac disorders Cardiac disorders - Other, specify	9.1% 1/11 • Number of events 1 • 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. 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.
Gastrointestinal disorders Constipation	9.1% 1/11 • Number of events 1 • 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. 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.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 1/11 • Number of events 1 • 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. 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.
Injury, poisoning and procedural complications Dermatitis radiation	81.8% 9/11 • Number of events 10 • 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. 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.
Gastrointestinal disorders Dysphagia	18.2% 2/11 • Number of events 2 • 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. 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 1/11 • Number of events 1 • 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. 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.
Gastrointestinal disorders Esophageal obstruction	9.1% 1/11 • Number of events 1 • 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. 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.
Gastrointestinal disorders Esophagitis	18.2% 2/11 • Number of events 2 • 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. 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.
General disorders Fatigue	54.5% 6/11 • Number of events 8 • 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. 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.
Investigations Forced expiratory volume decreased	18.2% 2/11 • Number of events 2 • 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. 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.
Gastrointestinal disorders Gastroesophageal reflux disease	27.3% 3/11 • Number of events 3 • 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. 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.
General disorders General disorders and administration site conditions - Other, specify	18.2% 2/11 • Number of events 2 • 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. 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.
Nervous system disorders Headache	9.1% 1/11 • Number of events 1 • 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. 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.
Vascular disorders Hot flashes	18.2% 2/11 • Number of events 2 • 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. 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.
Vascular disorders Hypertension	9.1% 1/11 • Number of events 1 • 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. 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.
Immune system disorders Immune system disorders - Other, specify	9.1% 1/11 • Number of events 1 • 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. 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.
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 1 • 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. 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.
Reproductive system and breast disorders Irregular menstruation	9.1% 1/11 • Number of events 1 • 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. 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.
Gastrointestinal disorders Nausea	18.2% 2/11 • Number of events 2 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	9.1% 1/11 • Number of events 1 • 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. 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.
General disorders Non-cardiac chest pain	9.1% 1/11 • Number of events 1 • 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. 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.
Musculoskeletal and connective tissue disorders Osteoporosis	9.1% 1/11 • Number of events 1 • 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. 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.
General disorders Pain	18.2% 2/11 • Number of events 2 • 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. 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.
Cardiac disorders Palpitations	9.1% 1/11 • Number of events 1 • 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. 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.
Nervous system disorders Paresthesia	9.1% 1/11 • Number of events 1 • 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. 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.
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • Number of events 1 • 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. 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.
Skin and subcutaneous tissue disorders Rash acneiform	9.1% 1/11 • Number of events 1 • 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. 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.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	9.1% 1/11 • Number of events 1 • 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. 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.
Cardiac disorders Sinus bradycardia	9.1% 1/11 • Number of events 1 • 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. 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.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	18.2% 2/11 • Number of events 2 • 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. 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.
Respiratory, thoracic and mediastinal disorders Sore throat	9.1% 1/11 • Number of events 2 • 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. 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.
Vascular disorders Thromboembolic event	9.1% 1/11 • Number of events 1 • 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. 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.
Ear and labyrinth disorders Tinnitus	9.1% 1/11 • Number of events 1 • 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. 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.
Infections and infestations Upper respiratory infection	9.1% 1/11 • Number of events 1 • 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. 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.
Gastrointestinal disorders Vomiting	9.1% 1/11 • Number of events 1 • 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. 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.
Investigations Weight loss	9.1% 1/11 • Number of events 1 • 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. 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.

Additional Information

Thomas F. DeLaney, MD

Massachusetts General Hospital

Phone: 617-726-6876

Email: TDELANEY@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place