Esophagus CancerNCT03482791

Proton Beam Therapy in the Treatment of Esophageal Cancer

A study testing Proton beam therapy and Patient-Reported Outcome Measures in people with Esophagus Cancer and Esophageal Cancer, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Esophagus Cancer, Esophageal Cancer, Cancer of the Esophagus
What is being tested?: Proton beam therapy and Patient-Reported Outcome Measures
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 19 Apr 2018to 9 Sep 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
Staged by PET/CT and esophagogastroduodenoscopy (EGD) or endoscopic ultrasound (EUS) OR CT w/contrast and EGD to have stage II or III disease per AJCC 7th edition guidelines
Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III esophageal cancer (AJCC 7th edition) is eligible, irrespective of margin status.
Induction chemotherapy prior to concurrent chemoradiation is allowed.
Prior thoracic radiation is allowable if degree of overlap with the esophageal radiotherapy treatment is deemed to be safe by the treating radiation oncologist.
At least 18 years of age.

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ECOG performance status < 2
Normal bone marrow and organ function as defined below:
WBC > 2,500/mcL
Platelets > 75,000/mcl
Total bilirubin < 1.5 x institutional upper limit of normal (IULN)
AST(SGOT)/ALT(SGPT) < 3.0 x IULN
Creatinine < 1.5 x IULN OR Creatinine clearance > 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Ability to understand and willingness to sign an IRB approved written informed consent document.
English speaker.
Financial coverage for proton therapy.

Who cannot join

Planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone.
Previous or concomitant cancers within the past 3 years other than curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, curative treatment for transitional cell carcinoma of the bladder, and low risk prostate cancer. Except for prostate cancer (which can be observed if low risk), other cancers listed must have been treated in the past 3 years without evidence of recurrence at the time of registration.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia not controlled by pacer device, myocardial infarction within 3 months of registration, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7 days of the start of treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase II Study of Proton Beam Therapy in the Treatment of Esophageal Cancer

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.

Conditions: Esophagus Cancer, Esophageal Cancer, Cancer of the Esophagus
Being tested: Proton beam therapy, Patient-Reported Outcome Measures
Medical subject headings: Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Proton beam therapyRadiation
Also called PBT
- The daily prescription dose will be 1.8 or 2 Gy RBE ("Relative Biologic Equivalence") to be delivered to the periphery of the planning target volume (PTV).
- The Mevion S-250 Proton Radiation Beam Therapy System will be used.
Patient-Reported Outcome MeasuresOther
Also called PROs
-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 8 weeks, 4, 6, 9, and 12-months following end of chemoradiation

Study groups in NCT03482791
Study group	Role	What they receive
Arm 1: Resectable (proton beam therapy)	Experimental	* 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 Receives: Radiation: Proton beam therapy; Other: Patient-Reported Outcome Measures
Arm 2: Unresectable (proton beam therapy)	Experimental	* 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 Receives: Radiation: Proton beam therapy; Other: Patient-Reported Outcome Measures

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Physician-reported Toxicity of PBT for Esophageal Cancer
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
Measured: Through 6 months following chemoradiation (estimated to be 9 months)
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score
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.
Measured: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Secondary outcomes (2)

Progression-free Survival (PFS) of Proton Beam Therapy (PBT) for Patients With Resectable
-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: 5 years following chemoradiation (estimated to be 5 years and 3 months)
Overall Survival (OS)of PBT for Patients With Resectable Versus Unresectable Esophageal
Measured: 5 years following chemoradiation (estimated to be 5 years and 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 20189 Sep 2026

First posted29 Mar 2018
Study start19 Apr 2018
Primary completion13 Sep 2022
Study completion9 Sep 2026

Why it stopped: The study is no longer relevant to have open to ensure insurance approval for this patient population

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Esophagus CancerStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03482791
Sponsor's protocol ID: 201803092
Status last verified: Sep 2026
First submitted: 15 Mar 2018
Last updated: 2 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 4
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
Barrett Esophagus
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma

All Esophagus Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Proton Beam Therapy in the Treatment of Esophageal Cancer
ClinicalTrials.gov ID: NCT03482791
Acronym / sponsor ID: 201803092
Conditions: Esophagus Cancer, Esophageal Cancer, Cancer of the Esophagus
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study is no longer relevant to have open to ensure insurance approval for this patient population
Enrolment: 22 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 19 Apr 2018 (actual)
Primary completion: 13 Sep 2022 (actual)
Study completion: 9 Sep 2026 (actual)
First posted: 29 Mar 2018 (actual)
Results: Posted 6 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1: Resectable (proton beam therapy)	Experimental	Radiation: Proton beam therapy, Other: Patient-Reported Outcome Measures* 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)	Experimental	Radiation: Proton beam therapy, Other: Patient-Reported Outcome Measures* 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Histologically or cytologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
Staged by PET/CT and esophagogastroduodenoscopy (EGD) or endoscopic ultrasound (EUS) OR CT w/contrast and EGD to have stage II or III disease per AJCC 7th edition guidelines
Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III esophageal cancer (AJCC 7th edition) is eligible, irrespective of margin status.
Induction chemotherapy prior to concurrent chemoradiation is allowed.
Prior thoracic radiation is allowable if degree of overlap with the esophageal radiotherapy treatment is deemed to be safe by the treating radiation oncologist.

Key exclusion criteria (4 listed)

Planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone.
Previous or concomitant cancers within the past 3 years other than curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, curative treatment for transitional cell carcinoma of the bladder, and low risk prostate cancer. Except for prostate cancer (which can be observed if low risk), other cancers listed must have been treated in the past 3 years without evidence of recurrence at the time of registration.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia not controlled by pacer device, myocardial infarction within 3 months of registration, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7 days of the start of treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Proton beam therapyAlso: PBT* The daily prescription dose will be 1.8 or 2 Gy RBE ("Relative Biologic Equivalence") to be delivered to the periphery of the planning target volume (PTV). * The Mevion S-250 Proton Radiation Beam Therapy System will be used.	Radiation	Arm 1: Resectable (proton beam therapy), Arm 2: Unresectable (proton beam therapy)
Patient-Reported Outcome MeasuresAlso: PROs-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 8 weeks, 4, 6, 9, and 12-months following end of chemoradiation	Other	Arm 1: Resectable (proton beam therapy), Arm 2: Unresectable (proton beam therapy)

Primary outcome

Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus
Time frame: 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire
Time frame: 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 "Best health state. The higher the score the better health a patient experienced.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey
Time frame: 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus
Time frame: 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire
Time frame: 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 "Best health state. The higher the score the better health a patient experienced.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey
Time frame: 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: 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.
Physician-reported Toxicity of PBT for Esophageal Cancer
Time frame: 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
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score
Time frame: 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 implemented in the QualityMetric PRO CoRE software package. MCS range is 40-65.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score
Time frame: 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 implemented in the QualityMetric PRO CoRE software package. PCS range is 30-55.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score
Time frame: 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 implemented in the QualityMetric PRO CoRE software package. PCS range is 30-55.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score
Time frame: 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. 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score
Time frame: 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). 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score
Time frame: 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 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score
Time frame: 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 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score
Time frame: 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 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score
Time frame: 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). 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score
Time frame: 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). 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score
Time frame: 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). 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.
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score
Time frame: 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 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.

2 secondary outcomes

Progression-free Survival (PFS) of Proton Beam Therapy (PBT) for Patients With Resectable
Time frame: 5 years following chemoradiation (estimated to be 5 years and 3 months)
Overall Survival (OS)of PBT for Patients With Resectable Versus Unresectable Esophageal
Time frame: 5 years following chemoradiation (estimated to be 5 years and 3 months)

Results and safety

Results posted to the registry on 6 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Resectable (Proton Beam Therapy)	16	15
Arm 2: Unresectable (Proton Beam Therapy)	6	6

Primary outcome: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus

Time frame: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm 1: Resectable (Proton Beam Therapy) n = 13	Arm 2: Unresectable (Proton Beam Therapy) n = 6
Baseline	1.994 (1.641)	1.127 (0.634)
Post completion of chemoradiation	4.135 (1.795)	3.024 (2.454)
2 months	1.012 (1)	1.31 (1.112)
4 months	2.429 (2.107)	1.714 (2.603)
6 months	1 (0.632)	0.738 (1.044)

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

Primary outcome: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire

Time frame: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm 1: Resectable (Proton Beam Therapy) n = 15	Arm 2: Unresectable (Proton Beam Therapy) n = 6
Baseline	0.664 (0.405)	0.486 (0.496)
Post completion of chemoradiation	0.56 (0.358)	0.607 (0.39)
2 months	0.803 (0.295)	0.818 (0.124)
4 months	0.802 (0.287)	0.645 (0.488)
6 months	0.816 (0.202)	0.942 (0.083)

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

Primary outcome: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey

Time frame: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm 1: Resectable (Proton Beam Therapy) n = 14	Arm 2: Unresectable (Proton Beam Therapy) n = 6
Baseline	89 (14.2)	71.1 (25.8)
Post completion of chemoradiation	88.2 (15.8)	83.4 (24.4)
2 months	90.2 (15.9)	98.4 (3.3)
4 months	88.5 (25.3)	84.2 (27.3)
6 months	88.2 (16.8)	98.7 (1.9)

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

Primary outcome: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)

Time frame: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm 1: Resectable (Proton Beam Therapy) n = 15	Arm 2: Unresectable (Proton Beam Therapy) n = 6
Baseline	19.763 (13.438)	16.355 (11.098)
Post completion of chemoradiation	16.67 (7.287)	15.914 (11.118)
2 months	12.47 (4.758)	14.15 (8.316)
4 months	12.47 (5.845)	14.15 (10.184)
6 months	11.21 (5.368)	11.21 (4.158)

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

2 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Resectable (Proton Beam Therapy)	12 of 15 (80%)	5 of 15 (33.3%)	8 of 15
Arm 2: Unresectable (Proton Beam Therapy)	4 of 6 (66.7%)	1 of 6 (16.7%)	4 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregory Vlacich, M.D., Ph.D. principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus (time frame: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03482791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.