Trial Outcomes & Findings for Proton Beam Therapy in the Treatment of Esophageal Cancer (NCT NCT03482791)

NCT ID: NCT03482791

Last Updated: 2025-04-06

Results Overview

The MDASI-Plus is a reliable, validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis. Patients are asked to fill out a twenty-seven question inventory. 21 questions ask the patient about the severity of their symptoms with answers ranging from 0=not present to 10=as bad as you can imagine. 6 questions ask the patient about how their symptoms interfered with their life with answers ranging from 0=did not interfere to 10=interfered completely. The higher the score the more severe symptom experience the patient experienced.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
• Results posted on: 2025-04-06

Participant Flow

Participant milestones

Measure	Arm 1: Resectable (Proton Beam Therapy) * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Overall Study STARTED	16	6
Overall Study COMPLETED	15	6
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Arm 1: Resectable (Proton Beam Therapy) * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Overall Study Patient did not start treatment due to physician decision	1	0

Baseline Characteristics

Proton Beam Therapy in the Treatment of Esophageal Cancer

Baseline characteristics by cohort

Measure	Arm 1: Resectable (Proton Beam Therapy) n=16 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=6 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points	Total n=22 Participants Total of all reporting groups
Age, Continuous	68.5 years n=5 Participants	77.5 years n=7 Participants	70.5 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	5 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	6 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	6 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The MDASI-Plus is a reliable, validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis. Patients are asked to fill out a twenty-seven question inventory. 21 questions ask the patient about the severity of their symptoms with answers ranging from 0=not present to 10=as bad as you can imagine. 6 questions ask the patient about how their symptoms interfered with their life with answers ranging from 0=did not interfere to 10=interfered completely. The higher the score the more severe symptom experience the patient experienced.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=13 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=6 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus Baseline	1.994 score on a scale Standard Deviation 1.641	1.127 score on a scale Standard Deviation 0.634
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus 4 months	2.429 score on a scale Standard Deviation 2.107	1.714 score on a scale Standard Deviation 2.603
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus Post completion of chemoradiation	4.135 score on a scale Standard Deviation 1.795	3.024 score on a scale Standard Deviation 2.454
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus 2 months	1.012 score on a scale Standard Deviation 1	1.31 score on a scale Standard Deviation 1.112
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus 6 months	1 score on a scale Standard Deviation 0.632	0.738 score on a scale Standard Deviation 1.044

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The EQ-5D is a standardized 2-part, patient-administered instrument used for direct and indirect assessment of health state utilities. The first part asks respondents to "check the ONE box [next to the appropriate statement] that best describes your health TODAY" for each of 5 health dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state. Both the 5-item index score and the VAS score are transformed into a utility score between 0 "Worst health state" and 1 "Best health state. The higher the score the better health a patient experienced.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=15 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=6 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire Baseline	0.664 score on a scale Standard Deviation 0.405	0.486 score on a scale Standard Deviation 0.496
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire Post completion of chemoradiation	0.56 score on a scale Standard Deviation 0.358	0.607 score on a scale Standard Deviation 0.39
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire 2 months	0.803 score on a scale Standard Deviation 0.295	0.818 score on a scale Standard Deviation 0.124
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire 4 months	0.802 score on a scale Standard Deviation 0.287	0.645 score on a scale Standard Deviation 0.488
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire 6 months	0.816 score on a scale Standard Deviation 0.202	0.942 score on a scale Standard Deviation 0.083

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The 19-item MOS Social Support Survey was designed for use with patients with chronic diseases and measures how often different kinds of support are available, if needed. Response choices range from "none of the time" (1) to "all of the time" (5). A mean social support score for all 19 items is computed to a 0-100 scale with higher scores indicating a greater availability of social support.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=14 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=6 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey Baseline	89 score on a scale Standard Deviation 14.2	71.1 score on a scale Standard Deviation 25.8
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey Post completion of chemoradiation	88.2 score on a scale Standard Deviation 15.8	83.4 score on a scale Standard Deviation 24.4
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey 2 months	90.2 score on a scale Standard Deviation 15.9	98.4 score on a scale Standard Deviation 3.3
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey 4 months	88.5 score on a scale Standard Deviation 25.3	84.2 score on a scale Standard Deviation 27.3
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey 6 months	88.2 score on a scale Standard Deviation 16.8	98.7 score on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The CES-D questionnaire is a 20-item measure which evaluates depressive symptoms. This trial will make use of the validated 4-item screening version in order to reduce participant burden. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=15 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=6 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) 2 months	12.47 score on a scale Standard Deviation 4.758	14.15 score on a scale Standard Deviation 8.316
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) Baseline	19.763 score on a scale Standard Deviation 13.438	16.355 score on a scale Standard Deviation 11.098
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) Post completion of chemoradiation	16.67 score on a scale Standard Deviation 7.287	15.914 score on a scale Standard Deviation 11.118
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) 4 months	12.47 score on a scale Standard Deviation 5.845	14.15 score on a scale Standard Deviation 10.184
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) 6 months	11.21 score on a scale Standard Deviation 5.368	11.21 score on a scale Standard Deviation 4.158

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The MDASI-Plus is a reliable, validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis. Patients are asked to fill out a twenty-seven question inventory. 21 questions ask the patient about the severity of their symptoms with answers ranging from 0=not present to 10=as bad as you can imagine. 6 questions ask the patient about how their symptoms interfered with their life with answers ranging from 0=did not interfere to 10=interfered completely. The higher the score the more severe symptom experience the patient experienced.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=14 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=6 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus Baseline	1.994 score on a scale Standard Deviation 1.641	1.127 score on a scale Standard Deviation 0.634
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus Post completion of chemoradiation	4.135 score on a scale Standard Deviation 1.795	3.024 score on a scale Standard Deviation 2.454
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus 2 months	1.012 score on a scale Standard Deviation 1	1.31 score on a scale Standard Deviation 1.112
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus 4 months	2.429 score on a scale Standard Deviation 2.107	1.714 score on a scale Standard Deviation 2.603
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus 6 months	1 score on a scale Standard Deviation 0.632	0.738 score on a scale Standard Deviation 1.044
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus 9 months	0.878 score on a scale Standard Deviation 0.858	2.476 score on a scale
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus 12 months	1.224 score on a scale Standard Deviation 1.319	0.524 score on a scale Standard Deviation 0.202

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The EQ-5D is a standardized 2-part, patient-administered instrument used for direct and indirect assessment of health state utilities. The first part asks respondents to "check the ONE box [next to the appropriate statement] that best describes your health TODAY" for each of 5 health dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state. Both the 5-item index score and the VAS score are transformed into a utility score between 0 "Worst health state" and 1 "Best health state. The higher the score the better health a patient experienced.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=15 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=6 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire 4 months	0.802 score on a scale Standard Deviation 0.287	0.645 score on a scale Standard Deviation 0.488
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire 12 months	0.84 score on a scale Standard Deviation 0.181	1 score on a scale Standard Deviation 0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire Baseline	0.664 score on a scale Standard Deviation 0.405	0.486 score on a scale Standard Deviation 0.496
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire Post completion of chemoradiation	0.56 score on a scale Standard Deviation 0.358	0.607 score on a scale Standard Deviation 0.39
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire 2 months	0.803 score on a scale Standard Deviation 0.295	0.818 score on a scale Standard Deviation 0.124
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire 6 months	0.816 score on a scale Standard Deviation 0.202	0.942 score on a scale Standard Deviation 0.083
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire 9 months	0.863 score on a scale Standard Deviation 0.161	0.734 score on a scale Standard Deviation 0.377

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The 19-item MOS Social Support Survey was designed for use with patients with chronic diseases and measures how often different kinds of support are available, if needed. Response choices range from "none of the time" (1) to "all of the time" (5). A mean social support score for all 19 items is computed to a 0-100 scale with higher scores indicating a greater availability of social support.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=14 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=6 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey 4 months	88.5 score on a scale Standard Deviation 25.3	84.2 score on a scale Standard Deviation 27.3
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey Baseline	89.0 score on a scale Standard Deviation 14.2	71.1 score on a scale Standard Deviation 25.8
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey Post completion of chemoradiation	88.2 score on a scale Standard Deviation 15.8	83.4 score on a scale Standard Deviation 24.4
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey 2 months	90.2 score on a scale Standard Deviation 15.9	98.4 score on a scale Standard Deviation 3.3
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey 6 months	88.2 score on a scale Standard Deviation 16.8	98.7 score on a scale Standard Deviation 1.9
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey 9 months	87.5 score on a scale Standard Deviation 18.8	99.3 score on a scale Standard Deviation 0.9
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey 12 months	91.8 score on a scale Standard Deviation 11.3	100 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The CES-D questionnaire is a 20-item measure which evaluates depressive symptoms. This trial will make use of the validated 4-item screening version in order to reduce participant burden. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=15 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=6 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) Baseline	19.763 score on a scale Standard Deviation 13.438	16.355 score on a scale Standard Deviation 11.098
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) Post completion of chemoradiation	16.67 score on a scale Standard Deviation 7.287	15.914 score on a scale Standard Deviation 11.118
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) 2 months	12.47 score on a scale Standard Deviation 4.758	14.15 score on a scale Standard Deviation 8.316
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) 4 months	12.47 score on a scale Standard Deviation 5.845	14.15 score on a scale Standard Deviation 10.184
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) 6 months	11.21 score on a scale Standard Deviation 5.368	11.21 score on a scale Standard Deviation 4.158
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) 9 months	12.89 score on a scale Standard Deviation 5.052	8.27 score on a scale Standard Deviation 0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) 12 months	12.843 score on a scale Standard Deviation 5.323	8.27 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Through 6 months following chemoradiation (estimated to be 9 months)

Number of participants with grade 3 or higher specific cardiac, metabolism/nutrition, gastrointestinal, respiratory/thoracic/mediastinal, and skin/subcutaneous toxicity using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 related to PBT

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=15 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=6 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Physician-reported Toxicity of PBT for Esophageal Cancer	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life.

MCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. MCS range is 40-65.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=11 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=5 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score 4 months	50.4 score on a scale Standard Deviation 10.2	44.6 score on a scale Standard Deviation 12.3
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score Baseline	45.0 score on a scale Standard Deviation 15.1	44.5 score on a scale Standard Deviation 16.4
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score Post completion of chemoradiation	45.7 score on a scale Standard Deviation 9.6	45.7 score on a scale Standard Deviation 13.0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score 2 months	50.9 score on a scale Standard Deviation 11.0	45.3 score on a scale Standard Deviation 15.9
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score 6 months	50.8 score on a scale Standard Deviation 8.2	54.7 score on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life.

PCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. PCS range is 30-55.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=11 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=5 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score 4 months	42.6 score on a scale Standard Deviation 13.3	42.9 score on a scale Standard Deviation 14.2
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score Baseline	45.8 score on a scale Standard Deviation 12.6	41.9 score on a scale Standard Deviation 18.1
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score Post completion of chemoradiation	33.5 score on a scale Standard Deviation 10.5	37.6 score on a scale Standard Deviation 11.4
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score 2 months	40.4 score on a scale Standard Deviation 12.0	39.4 score on a scale Standard Deviation 12.6
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score 6 months	42.3 score on a scale Standard Deviation 12.0	51.9 score on a scale Standard Deviation 6.1

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life.

PCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. PCS range is 30-55.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=11 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=5 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score 4 months	42.6 score on a scale Standard Deviation 13.3	42.9 score on a scale Standard Deviation 14.2
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score Baseline	45.8 score on a scale Standard Deviation 12.6	41.9 score on a scale Standard Deviation 18.1
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score Post completion of chemoradiation	33.5 score on a scale Standard Deviation 10.5	37.6 score on a scale Standard Deviation 11.4
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score 2 months	40.4 score on a scale Standard Deviation 12.0	39.4 score on a scale Standard Deviation 12.6
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score 6 months	42.3 score on a scale Standard Deviation 12.0	51.9 score on a scale Standard Deviation 6.1
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score 9 months	43.9 score on a scale Standard Deviation 9.8	40.4 score on a scale Standard Deviation 17.6
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score 12 months	42.1 score on a scale Standard Deviation 11.1	39.8 score on a scale Standard Deviation 7.2

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life.

MCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. MCS range is 40-65.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=11 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=5 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score Post completion of chemoradiation	45.7 score on a scale Standard Deviation 9.6	45.7 score on a scale Standard Deviation 13.0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score 9 months	48.2 score on a scale Standard Deviation 8.6	47.9 score on a scale Standard Deviation 16.0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score 12 months	51.6 score on a scale Standard Deviation 7.9	61.4 score on a scale Standard Deviation 5.3
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score Baseline	45.0 score on a scale Standard Deviation 15.1	44.5 score on a scale Standard Deviation 16.4
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score 2 months	50.9 score on a scale Standard Deviation 11.0	45.3 score on a scale Standard Deviation 15.9
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score 4 months	50.4 score on a scale Standard Deviation 10.2	44.6 score on a scale Standard Deviation 12.3
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score 6 months	50.8 score on a scale Standard Deviation 8.2	54.7 score on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=11 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=5 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score 2 months	2.5 score on a scale Standard Deviation 0.8	3.2 score on a scale Standard Deviation 1.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score 9 months	3.1 score on a scale Standard Deviation 0.9	3 score on a scale Standard Deviation 1.4
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score 12 months	3.1 score on a scale Standard Deviation 1	2 score on a scale Standard Deviation 0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score Baseline	3 score on a scale Standard Deviation 1.3	3.5 score on a scale Standard Deviation 1.9
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score Post completion of chemoradiation	3.1 score on a scale Standard Deviation 0.9	2.8 score on a scale Standard Deviation 1.1
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score 4 months	3 score on a scale Standard Deviation 0.8	3 score on a scale Standard Deviation 1
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score 6 months	3.1 score on a scale Standard Deviation 1.1	2.5 score on a scale Standard Deviation 0.7

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-3.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=11 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=5 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score Baseline	2.6 score on a scale Standard Deviation 0.7	2.6 score on a scale Standard Deviation 0.7
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score 6 months	2.4 score on a scale Standard Deviation 0.6	2.5 score on a scale Standard Deviation 1
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score 9 months	2.3 score on a scale Standard Deviation 0.6	1.8 score on a scale Standard Deviation 1
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score Post completion of chemoradiation	1.9 score on a scale Standard Deviation 0.6	1.7 score on a scale Standard Deviation 0.8
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score 2 months	2.1 score on a scale Standard Deviation 0.8	1.9 score on a scale Standard Deviation 0.8
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score 4 months	2.2 score on a scale Standard Deviation 0.7	2.2 score on a scale Standard Deviation 1
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score 12 months	2.4 score on a scale Standard Deviation 0.8	1.8 score on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-2.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=11 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=5 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score Baseline	1.5 score on a scale Standard Deviation 0.5	1.5 score on a scale Standard Deviation 0.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score Post completion of chemoradiation	1.1 score on a scale Standard Deviation 0.4	1.3 score on a scale Standard Deviation 0.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score 2 months	1.5 score on a scale Standard Deviation 0.5	1.2 score on a scale Standard Deviation 0.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score 4 months	1.5 score on a scale Standard Deviation 0.5	1.3 score on a scale Standard Deviation 0.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score 6 months	1.5 score on a scale Standard Deviation 0.5	2 score on a scale Standard Deviation 0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score 9 months	1.5 score on a scale Standard Deviation 0.5	1.5 score on a scale Standard Deviation 0.6
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score 12 months	1.5 score on a scale Standard Deviation 0.5	1.5 score on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-2.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=11 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=5 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score 2 months	1.7 score on a scale Standard Deviation 0.5	1.5 score on a scale Standard Deviation 0.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score 9 months	1.6 score on a scale Standard Deviation 0.5	1.5 score on a scale Standard Deviation 0.6
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score Baseline	1.6 score on a scale Standard Deviation 0.5	1.8 score on a scale Standard Deviation 0.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score Post completion of chemoradiation	1.6 score on a scale Standard Deviation 0.5	1.5 score on a scale Standard Deviation 0.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score 4 months	1.5 score on a scale Standard Deviation 0.5	1.3 score on a scale Standard Deviation 0.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score 6 months	1.8 score on a scale Standard Deviation 0.4	2 score on a scale Standard Deviation 0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score 12 months	1.8 score on a scale Standard Deviation 0.4	2 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=11 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=5 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score Baseline	2.1 score on a scale Standard Deviation 1.3	2.5 score on a scale Standard Deviation 1.9
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score Post completion of chemoradiation	3.1 score on a scale Standard Deviation 1.2	2 score on a scale Standard Deviation 1.2
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score 2 months	2.6 score on a scale Standard Deviation 1.5	1.5 score on a scale Standard Deviation 1
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score 4 months	2 score on a scale Standard Deviation 1.5	1.7 score on a scale Standard Deviation 1.2
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score 6 months	1.9 score on a scale Standard Deviation 1.1	1 score on a scale Standard Deviation 0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score 9 months	1.6 score on a scale Standard Deviation 0.5	2 score on a scale Standard Deviation 1.4
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score 12 months	2 score on a scale Standard Deviation 1.1	1.5 score on a scale Standard Deviation 0.7

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-6.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=11 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=5 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score 12 months	2.1 score on a scale Standard Deviation 1.0	1.5 score on a scale Standard Deviation 0.6
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score Baseline	2.8 score on a scale Standard Deviation 1.4	2.8 score on a scale Standard Deviation 1.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score Post completion of chemoradiation	2.9 score on a scale Standard Deviation 1.1	2.7 score on a scale Standard Deviation 1.3
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score 2 months	2.1 score on a scale Standard Deviation 1.0	2.6 score on a scale Standard Deviation 1.6
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score 4 months	1.9 score on a scale Standard Deviation 0.9	2.5 score on a scale Standard Deviation 1.4
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score 6 months	2.1 score on a scale Standard Deviation 1.4	2.2 score on a scale Standard Deviation 1.0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score 9 months	2.5 score on a scale Standard Deviation 1.0	2.8 score on a scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-6.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=11 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=5 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score Baseline	3.5 score on a scale Standard Deviation 1.5	4 score on a scale Standard Deviation 2.3
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score 4 months	3.6 score on a scale Standard Deviation 1.7	3.7 score on a scale Standard Deviation 1.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score Post completion of chemoradiation	4.4 score on a scale Standard Deviation 1	4.4 score on a scale Standard Deviation 1.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score 2 months	3.4 score on a scale Standard Deviation 1.1	4.2 score on a scale Standard Deviation 1.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score 6 months	3.6 score on a scale Standard Deviation 1.6	3 score on a scale Standard Deviation 1.4
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score 9 months	3.1 score on a scale Standard Deviation 1.5	3.5 score on a scale Standard Deviation 2.1
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score 12 months	3.4 score on a scale Standard Deviation 1.5	3 score on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Population: Participants who did not complete the questionnaires are not included in this outcome measure.

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5.

Outcome measures

Measure	Arm 1: Resectable (Proton Beam Therapy) n=11 Participants * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=5 Participants * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score Baseline	3.9 score on a scale Standard Deviation 1.4	3 score on a scale Standard Deviation 1.8
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score Post completion of chemoradiation	2.9 score on a scale Standard Deviation 1.3	3.4 score on a scale Standard Deviation 1.3
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score 2 months	3.6 score on a scale Standard Deviation 1.4	3.8 score on a scale Standard Deviation 1
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score 4 months	4.3 score on a scale Standard Deviation 1.3	3.7 score on a scale Standard Deviation 1.5
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score 6 months	4 score on a scale Standard Deviation 1.2	5 score on a scale Standard Deviation 0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score 9 months	3.9 score on a scale Standard Deviation 1.3	4 score on a scale Standard Deviation 1.4
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score 12 months	4 score on a scale Standard Deviation 1.1	4.5 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 5 years following chemoradiation (estimated to be 5 years and 3 months)

-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years following chemoradiation (estimated to be 5 years and 3 months)

Outcome measures

Outcome data not reported

Adverse Events

Arm 1: Resectable (Proton Beam Therapy)

Serious events: 12 serious events

Other events: 5 other events

Deaths: 8 deaths

Arm 2: Unresectable (Proton Beam Therapy)

Serious events: 4 serious events

Other events: 1 other events

Deaths: 4 deaths

Serious adverse events

Measure	Arm 1: Resectable (Proton Beam Therapy) n=15 participants at risk * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=6 participants at risk * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Blood and lymphatic system disorders Febrile neutropenia	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Cardiac disorders Atrioventricular block first degree	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Cardiac disorders Chest pain-cardiac	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Cardiac disorders Heart failure	0.00% 0/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	16.7% 1/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Cardiac disorders Pericardial effusion	0.00% 0/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	16.7% 1/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Cardiac disorders Pericardial tamponade	0.00% 0/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	16.7% 1/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Gastrointestinal disorders Abdominal distension	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Gastrointestinal disorders Ascites	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Gastrointestinal disorders Dysphagia	13.3% 2/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Gastrointestinal disorders Enterocolitis	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Gastrointestinal disorders Esophagitis	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Gastrointestinal disorders Gastric ulcer	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Gastrointestinal disorders Hemorrhoidal hemorrhage	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Infections and infestations Abdominal infection	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Infections and infestations COVID-19 infection	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Infections and infestations Sepsis	13.3% 2/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Metabolism and nutrition disorders Anorexia	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Metabolism and nutrition disorders Dehydration	13.3% 2/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Musculoskeletal and connective tissue disorders Back pain	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	13.3% 2/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	26.7% 4/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	16.7% 1/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Respiratory, thoracic and mediastinal disorders ACE induced cough	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	16.7% 1/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	16.7% 1/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary artery pseudoaneurysm	0.00% 0/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	16.7% 1/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	16.7% 1/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Injury, poisoning and procedural complications Wound dehiscence	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Vascular disorders Hematoma	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Vascular disorders Thromboembolic event	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.

Other adverse events

Measure	Arm 1: Resectable (Proton Beam Therapy) n=15 participants at risk * Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points	Arm 2: Unresectable (Proton Beam Therapy) n=6 participants at risk * Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Gastrointestinal disorders Gastric stenosis	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Infections and infestations Hepatitis viral	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Infections and infestations Sepsis	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Musculoskeletal and connective tissue disorders Flank pain	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Respiratory, thoracic and mediastinal disorders Aspiration	6.7% 1/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	0.00% 0/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/15 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.	16.7% 1/6 • Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.

Additional Information

Gregory Vlacich, M.D., Ph.D.

Washington University School of Medicine

Phone: 314-362-8610

Email: gvlacich@wustl.edu

Results disclosure agreements

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