An interventional study of Proton beam therapy and Patient-Reported Outcome Measures in Esophagus Cancer, Esophageal Cancer and Cancer of the Esophagus, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
The study is no longer relevant to have open to ensure insurance approval for this patient population
Among 14 studies in Esophageal Neoplasms by Washington University School of Medicine — 2 open to participants now, 3 under way, none of them phase 3. Esophageal Neoplasms · Washington University School of Medicine.
Among the 14 studies in Esophageal Neoplasms by Washington University School of Medicine, this one is the 7th largest by enrollment of the 12 interventional ones, is the only one that started in 2018, is one of 4 with no phase, and was the 8th registered.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
This study's enrollment of 22 is below the median of 58 across 1,347 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →2 of the 14 studies in Esophageal Neoplasms by Washington University School of Medicine are open now, in 1 country. Each count lists the studies.
Of the 387 Esophageal Neoplasms studies recruiting now, 245 (63%) set no upper age limit and 75 (19%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2018.
Median enrollment 23 across the 12 interventional studies, 206 across the 2 observational. Of the 10 that completed or were terminated, 6 (60%) have results posted.
Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
1 of the studies in Esophageal Neoplasms by Washington University School of Medicine that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04354064Washington University School of MedicineCirculating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors | 2026-12-31 |
Among the 14 studies in Esophageal Neoplasms by Washington University School of Medicine, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Normal bone marrow and organ function as defined below:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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
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
Radiation: Proton beam therapy · Other: Patient-Reported Outcome Measures
* 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.
Also known as: PBT
-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
Also known as: PROs
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
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.
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)
| Milestone | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Started | 16 | 6 |
| Completed | 15 | 6 |
| Not completed | 1 | 0 |
| Withdrew: Patient did not start treatment due to physician decision | 1 | 0 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| 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 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| 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 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| 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 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| 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 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| 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 |
| 9 months | 0.878 ± 0.858 | 2.476 |
| 12 months | 1.224 ± 1.319 | 0.524 ± 0.202 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| 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 |
| 9 months | 0.863 ± 0.161 | 0.734 ± 0.377 |
| 12 months | 0.84 ± 0.181 | 1 ± 0 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 89.0 ± 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 |
| 9 months | 87.5 ± 18.8 | 99.3 ± 0.9 |
| 12 months | 91.8 ± 11.3 | 100 ± 0 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| 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 |
| 9 months | 12.89 ± 5.052 | 8.27 ± 0 |
| 12 months | 12.843 ± 5.323 | 8.27 ± 0 |
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
| Participants | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Physician-reported Toxicity of PBT for Esophageal Cancer | 2 | 0 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 45.0 ± 15.1 | 44.5 ± 16.4 |
| Post completion of chemoradiation | 45.7 ± 9.6 | 45.7 ± 13.0 |
| 2 months | 50.9 ± 11.0 | 45.3 ± 15.9 |
| 4 months | 50.4 ± 10.2 | 44.6 ± 12.3 |
| 6 months | 50.8 ± 8.2 | 54.7 ± 1.4 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 45.8 ± 12.6 | 41.9 ± 18.1 |
| Post completion of chemoradiation | 33.5 ± 10.5 | 37.6 ± 11.4 |
| 2 months | 40.4 ± 12.0 | 39.4 ± 12.6 |
| 4 months | 42.6 ± 13.3 | 42.9 ± 14.2 |
| 6 months | 42.3 ± 12.0 | 51.9 ± 6.1 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 45.8 ± 12.6 | 41.9 ± 18.1 |
| Post completion of chemoradiation | 33.5 ± 10.5 | 37.6 ± 11.4 |
| 2 months | 40.4 ± 12.0 | 39.4 ± 12.6 |
| 4 months | 42.6 ± 13.3 | 42.9 ± 14.2 |
| 6 months | 42.3 ± 12.0 | 51.9 ± 6.1 |
| 9 months | 43.9 ± 9.8 | 40.4 ± 17.6 |
| 12 months | 42.1 ± 11.1 | 39.8 ± 7.2 |
-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 45.0 ± 15.1 | 44.5 ± 16.4 |
| Post completion of chemoradiation | 45.7 ± 9.6 | 45.7 ± 13.0 |
| 2 months | 50.9 ± 11.0 | 45.3 ± 15.9 |
| 4 months | 50.4 ± 10.2 | 44.6 ± 12.3 |
| 6 months | 50.8 ± 8.2 | 54.7 ± 1.4 |
| 9 months | 48.2 ± 8.6 | 47.9 ± 16.0 |
| 12 months | 51.6 ± 7.9 | 61.4 ± 5.3 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 3 ± 1.3 | 3.5 ± 1.9 |
| Post completion of chemoradiation | 3.1 ± 0.9 | 2.8 ± 1.1 |
| 2 months | 2.5 ± 0.8 | 3.2 ± 1.5 |
| 4 months | 3 ± 0.8 | 3 ± 1 |
| 6 months | 3.1 ± 1.1 | 2.5 ± 0.7 |
| 9 months | 3.1 ± 0.9 | 3 ± 1.4 |
| 12 months | 3.1 ± 1 | 2 ± 0 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 2.6 ± 0.7 | 2.6 ± 0.7 |
| Post completion of chemoradiation | 1.9 ± 0.6 | 1.7 ± 0.8 |
| 2 months | 2.1 ± 0.8 | 1.9 ± 0.8 |
| 4 months | 2.2 ± 0.7 | 2.2 ± 1 |
| 6 months | 2.4 ± 0.6 | 2.5 ± 1 |
| 9 months | 2.3 ± 0.6 | 1.8 ± 1 |
| 12 months | 2.4 ± 0.8 | 1.8 ± 0.5 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 1.5 ± 0.5 | 1.5 ± 0.5 |
| Post completion of chemoradiation | 1.1 ± 0.4 | 1.3 ± 0.5 |
| 2 months | 1.5 ± 0.5 | 1.2 ± 0.5 |
| 4 months | 1.5 ± 0.5 | 1.3 ± 0.5 |
| 6 months | 1.5 ± 0.5 | 2 ± 0 |
| 9 months | 1.5 ± 0.5 | 1.5 ± 0.6 |
| 12 months | 1.5 ± 0.5 | 1.5 ± 0.6 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 1.6 ± 0.5 | 1.8 ± 0.5 |
| Post completion of chemoradiation | 1.6 ± 0.5 | 1.5 ± 0.5 |
| 2 months | 1.7 ± 0.5 | 1.5 ± 0.5 |
| 4 months | 1.5 ± 0.5 | 1.3 ± 0.5 |
| 6 months | 1.8 ± 0.4 | 2 ± 0 |
| 9 months | 1.6 ± 0.5 | 1.5 ± 0.6 |
| 12 months | 1.8 ± 0.4 | 2 ± 0 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 2.1 ± 1.3 | 2.5 ± 1.9 |
| Post completion of chemoradiation | 3.1 ± 1.2 | 2 ± 1.2 |
| 2 months | 2.6 ± 1.5 | 1.5 ± 1 |
| 4 months | 2 ± 1.5 | 1.7 ± 1.2 |
| 6 months | 1.9 ± 1.1 | 1 ± 0 |
| 9 months | 1.6 ± 0.5 | 2 ± 1.4 |
| 12 months | 2 ± 1.1 | 1.5 ± 0.7 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 2.8 ± 1.4 | 2.8 ± 1.5 |
| Post completion of chemoradiation | 2.9 ± 1.1 | 2.7 ± 1.3 |
| 2 months | 2.1 ± 1.0 | 2.6 ± 1.6 |
| 4 months | 1.9 ± 0.9 | 2.5 ± 1.4 |
| 6 months | 2.1 ± 1.4 | 2.2 ± 1.0 |
| 9 months | 2.5 ± 1.0 | 2.8 ± 2.2 |
| 12 months | 2.1 ± 1.0 | 1.5 ± 0.6 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 3.5 ± 1.5 | 4 ± 2.3 |
| Post completion of chemoradiation | 4.4 ± 1 | 4.4 ± 1.5 |
| 2 months | 3.4 ± 1.1 | 4.2 ± 1.5 |
| 4 months | 3.6 ± 1.7 | 3.7 ± 1.5 |
| 6 months | 3.6 ± 1.6 | 3 ± 1.4 |
| 9 months | 3.1 ± 1.5 | 3.5 ± 2.1 |
| 12 months | 3.4 ± 1.5 | 3 ± 1.4 |
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.
| score on a scale | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Baseline | 3.9 ± 1.4 | 3 ± 1.8 |
| Post completion of chemoradiation | 2.9 ± 1.3 | 3.4 ± 1.3 |
| 2 months | 3.6 ± 1.4 | 3.8 ± 1 |
| 4 months | 4.3 ± 1.3 | 3.7 ± 1.5 |
| 6 months | 4 ± 1.2 | 5 ± 0 |
| 9 months | 3.9 ± 1.3 | 4 ± 1.4 |
| 12 months | 4 ± 1.1 | 4.5 ± 0.7 |
Collected over Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | 8/15 (53.3%) | 12/15 (80%) | 5/15 (33.3%) |
| Arm 2: Unresectable (Proton Beam Therapy) | 4/6 (66.7%) | 4/6 (66.7%) | 1/6 (16.7%) |
| Event | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| Disease progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/15 | 1/6 |
| Heart failureCardiac disorders | 0/15 | 1/6 |
| Pericardial effusionCardiac disorders | 0/15 | 1/6 |
| Pericardial tamponadeCardiac disorders | 0/15 | 1/6 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/15 | 1/6 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/15 | 1/6 |
| Pulmonary artery pseudoaneurysmRespiratory, thoracic and mediastinal disorders | 0/15 | 1/6 |
| CellulitisSkin and subcutaneous tissue disorders | 0/15 | 1/6 |
| DysphagiaGastrointestinal disorders | 2/15 | 0/6 |
| SepsisInfections and infestations | 2/15 | 0/6 |
| Event | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/15 | 1/6 |
| DiarrheaGastrointestinal disorders | 1/15 | 0/6 |
| Gastric stenosisGastrointestinal disorders | 1/15 | 0/6 |
| Hepatitis viralInfections and infestations | 1/15 | 0/6 |
| SepsisInfections and infestations | 1/15 | 0/6 |
| Flank painMusculoskeletal and connective tissue disorders | 1/15 | 0/6 |
| AspirationRespiratory, thoracic and mediastinal disorders | 1/15 | 0/6 |
| Age, Continuous(years) | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) | Total |
|---|---|---|---|
| Median | 68.5 (52 to 78) | 77.5 (55 to 84) | 70.5 (52 to 84) |
| Sex: Female, Male(Participants) | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 12 | 4 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 16 | 5 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 15 | 6 | 21 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm 1: Resectable (Proton Beam Therapy) | Arm 2: Unresectable (Proton Beam Therapy) | Total |
|---|---|---|---|
| United States | 16 | 6 | 22 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Sep 2022, 52 months.
Results were first posted in Apr 2025, 2 years 6 months after primary completion.
Completion moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Oct 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
The study is no longer relevant to have open to ensure insurance approval for this patient population
The study is no longer relevant to have open to ensure insurance approval for this patient population
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine →