18 and older, any sex, with Esophagus Cancer or Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-PlusPrimary· Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
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.
Baseline
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
1.994
± 1.641
Arm 2: Unresectable (Proton Beam Therapy)
1.127
± 0.634
Post completion of chemoradiation
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
4.135
± 1.795
Arm 2: Unresectable (Proton Beam Therapy)
3.024
± 2.454
2 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
1.012
± 1
Arm 2: Unresectable (Proton Beam Therapy)
1.31
± 1.112
4 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
2.429
± 2.107
Arm 2: Unresectable (Proton Beam Therapy)
1.714
± 2.603
6 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
1
± 0.632
Arm 2: Unresectable (Proton Beam Therapy)
0.738
± 1.044
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) QuestionnairePrimary· Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
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
Baseline
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.664
± 0.405
Arm 2: Unresectable (Proton Beam Therapy)
0.486
± 0.496
Post completion of chemoradiation
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.56
± 0.358
Arm 2: Unresectable (Proton Beam Therapy)
0.607
± 0.39
2 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.803
± 0.295
Arm 2: Unresectable (Proton Beam Therapy)
0.818
± 0.124
4 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.802
± 0.287
Arm 2: Unresectable (Proton Beam Therapy)
0.645
± 0.488
6 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.816
± 0.202
Arm 2: Unresectable (Proton Beam Therapy)
0.942
± 0.083
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support SurveyPrimary· Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
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.
Baseline
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
89
± 14.2
Arm 2: Unresectable (Proton Beam Therapy)
71.1
± 25.8
Post completion of chemoradiation
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
88.2
± 15.8
Arm 2: Unresectable (Proton Beam Therapy)
83.4
± 24.4
2 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
90.2
± 15.9
Arm 2: Unresectable (Proton Beam Therapy)
98.4
± 3.3
4 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
88.5
± 25.3
Arm 2: Unresectable (Proton Beam Therapy)
84.2
± 27.3
6 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
88.2
± 16.8
Arm 2: Unresectable (Proton Beam Therapy)
98.7
± 1.9
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)Primary· Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
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.
Baseline
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
19.763
± 13.438
Arm 2: Unresectable (Proton Beam Therapy)
16.355
± 11.098
Post completion of chemoradiation
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
16.67
± 7.287
Arm 2: Unresectable (Proton Beam Therapy)
15.914
± 11.118
2 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
12.47
± 4.758
Arm 2: Unresectable (Proton Beam Therapy)
14.15
± 8.316
4 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
12.47
± 5.845
Arm 2: Unresectable (Proton Beam Therapy)
14.15
± 10.184
6 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
11.21
± 5.368
Arm 2: Unresectable (Proton Beam Therapy)
11.21
± 4.158
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-PlusPrimary· Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
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.
Baseline
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
1.994
± 1.641
Arm 2: Unresectable (Proton Beam Therapy)
1.127
± 0.634
Post completion of chemoradiation
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
4.135
± 1.795
Arm 2: Unresectable (Proton Beam Therapy)
3.024
± 2.454
2 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
1.012
± 1
Arm 2: Unresectable (Proton Beam Therapy)
1.31
± 1.112
4 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
2.429
± 2.107
Arm 2: Unresectable (Proton Beam Therapy)
1.714
± 2.603
6 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
1
± 0.632
Arm 2: Unresectable (Proton Beam Therapy)
0.738
± 1.044
9 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.878
± 0.858
Arm 2: Unresectable (Proton Beam Therapy)
2.476
12 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
1.224
± 1.319
Arm 2: Unresectable (Proton Beam Therapy)
0.524
± 0.202
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) QuestionnairePrimary· Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
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
Baseline
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.664
± 0.405
Arm 2: Unresectable (Proton Beam Therapy)
0.486
± 0.496
Post completion of chemoradiation
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.56
± 0.358
Arm 2: Unresectable (Proton Beam Therapy)
0.607
± 0.39
2 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.803
± 0.295
Arm 2: Unresectable (Proton Beam Therapy)
0.818
± 0.124
4 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.802
± 0.287
Arm 2: Unresectable (Proton Beam Therapy)
0.645
± 0.488
6 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.816
± 0.202
Arm 2: Unresectable (Proton Beam Therapy)
0.942
± 0.083
9 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.863
± 0.161
Arm 2: Unresectable (Proton Beam Therapy)
0.734
± 0.377
12 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
0.84
± 0.181
Arm 2: Unresectable (Proton Beam Therapy)
1
± 0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support SurveyPrimary· Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
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.
Baseline
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
89.0
± 14.2
Arm 2: Unresectable (Proton Beam Therapy)
71.1
± 25.8
Post completion of chemoradiation
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
88.2
± 15.8
Arm 2: Unresectable (Proton Beam Therapy)
83.4
± 24.4
2 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
90.2
± 15.9
Arm 2: Unresectable (Proton Beam Therapy)
98.4
± 3.3
4 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
88.5
± 25.3
Arm 2: Unresectable (Proton Beam Therapy)
84.2
± 27.3
6 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
88.2
± 16.8
Arm 2: Unresectable (Proton Beam Therapy)
98.7
± 1.9
9 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
87.5
± 18.8
Arm 2: Unresectable (Proton Beam Therapy)
99.3
± 0.9
12 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
91.8
± 11.3
Arm 2: Unresectable (Proton Beam Therapy)
100
± 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)Primary· Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
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.
Baseline
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
19.763
± 13.438
Arm 2: Unresectable (Proton Beam Therapy)
16.355
± 11.098
Post completion of chemoradiation
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
16.67
± 7.287
Arm 2: Unresectable (Proton Beam Therapy)
15.914
± 11.118
2 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
12.47
± 4.758
Arm 2: Unresectable (Proton Beam Therapy)
14.15
± 8.316
4 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
12.47
± 5.845
Arm 2: Unresectable (Proton Beam Therapy)
14.15
± 10.184
6 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
11.21
± 5.368
Arm 2: Unresectable (Proton Beam Therapy)
11.21
± 4.158
9 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
12.89
± 5.052
Arm 2: Unresectable (Proton Beam Therapy)
8.27
± 0
12 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
12.843
± 5.323
Arm 2: Unresectable (Proton Beam Therapy)
8.27
± 0
Physician-reported Toxicity of PBT for Esophageal CancerPrimary· 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
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
2
Arm 2: Unresectable (Proton Beam Therapy)
0
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component ScorePrimary· Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
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 implemente
Baseline
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
45.0
± 15.1
Arm 2: Unresectable (Proton Beam Therapy)
44.5
± 16.4
Post completion of chemoradiation
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
45.7
± 9.6
Arm 2: Unresectable (Proton Beam Therapy)
45.7
± 13.0
2 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
50.9
± 11.0
Arm 2: Unresectable (Proton Beam Therapy)
45.3
± 15.9
4 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
50.4
± 10.2
Arm 2: Unresectable (Proton Beam Therapy)
44.6
± 12.3
6 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
50.8
± 8.2
Arm 2: Unresectable (Proton Beam Therapy)
54.7
± 1.4
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component ScorePrimary· Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
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 implemente
Baseline
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
45.8
± 12.6
Arm 2: Unresectable (Proton Beam Therapy)
41.9
± 18.1
Post completion of chemoradiation
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
33.5
± 10.5
Arm 2: Unresectable (Proton Beam Therapy)
37.6
± 11.4
2 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
40.4
± 12.0
Arm 2: Unresectable (Proton Beam Therapy)
39.4
± 12.6
4 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
42.6
± 13.3
Arm 2: Unresectable (Proton Beam Therapy)
42.9
± 14.2
6 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
42.3
± 12.0
Arm 2: Unresectable (Proton Beam Therapy)
51.9
± 6.1
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component ScorePrimary· Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
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 implemente
Baseline
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
45.8
± 12.6
Arm 2: Unresectable (Proton Beam Therapy)
41.9
± 18.1
Post completion of chemoradiation
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
33.5
± 10.5
Arm 2: Unresectable (Proton Beam Therapy)
37.6
± 11.4
2 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
40.4
± 12.0
Arm 2: Unresectable (Proton Beam Therapy)
39.4
± 12.6
4 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
42.6
± 13.3
Arm 2: Unresectable (Proton Beam Therapy)
42.9
± 14.2
6 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
42.3
± 12.0
Arm 2: Unresectable (Proton Beam Therapy)
51.9
± 6.1
9 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
43.9
± 9.8
Arm 2: Unresectable (Proton Beam Therapy)
40.4
± 17.6
12 months
Group
Value
95% CI
Arm 1: Resectable (Proton Beam Therapy)
42.1
± 11.1
Arm 2: Unresectable (Proton Beam Therapy)
39.8
± 7.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm 1: Resectable (Proton Beam Therapy)
Serious: 12/15 (80%)
Deaths: 8/15
Arm 2: Unresectable (Proton Beam Therapy)
Serious: 4/6 (67%)
Deaths: 4/6
Serious adverse events (31 terms)
Reaction
System
Arm 1: Resectable (Proton …
Arm 2: Unresectable (Proto…
Disease progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The investigators plan to include both operable and inoperable patients with esophagus cancer in this prospective trial. Since both proton and photon treatments are biologically equivalent, the investigators do not expect a difference in tumor control compared to intensity modulated radiation therapy (IMRT). The investigators have a prospective experience of physician-reported toxicity and patient outcome using IMRT for patients with inoperable esophagus cancer that will serve as a comparison group. For the resectable patients receiving trimodality therapy (chemoradiation followed by surgery), the investigators will carefully track toxicity and patient outcomes prospectively. The central hypothesis is that the biologic efficacy for tumor control should be similar between protons and photons, and therefore survival measures should be similar between the two groups, but that the main difference lies in the total severe toxicities experienced by the patients undergoing therapy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 2 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03482791.