Esophagus Cancer, Esophageal Cancer, Cancer of the Esophagus
Conditions
Brief summary
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.
Interventions
RADIATIONProton beam therapy
* 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.
-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
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 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 | 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 | 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) | 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. |
| Physician-reported Toxicity of PBT for Esophageal Cancer | 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 | 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 | 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 - General Health Score | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) of Proton Beam Therapy (PBT) for Patients With Resectable | 5 years following chemoradiation (estimated to be 5 years and 3 months) | -PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. |
| Overall Survival (OS)of PBT for Patients With Resectable Versus Unresectable Esophageal | 5 years following chemoradiation (estimated to be 5 years and 3 months) | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGregory Vlacich, M.D., Ph.D.
Washington University School of Medicine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Resectable (Proton Beam Therapy) * Proton beam therapy: total dose of 50 or 50.4 Gy
* Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision
* Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation
* Patient-reported outcome measures (PROs) performed at several time points | 16 |
| Arm 2: Unresectable (Proton Beam Therapy) * Proton beam therapy: total dose of 59.4 or 60 Gy
* Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision
* Patient-reported outcome measures (PROs) performed at several time points | 6 |
| Total | 22 |
Baseline characteristics
| Characteristic | Arm 1: Resectable (Proton Beam Therapy) | Total | Arm 2: Unresectable (Proton Beam Therapy) |
|---|---|---|---|
| Age, Continuous | 68.5 years | 70.5 years | 77.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 21 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 21 Participants | 6 Participants |
| Region of Enrollment United States | 16 participants | 22 participants | 6 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 12 Participants | 16 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 15 | 4 / 6 |
| other Total, other adverse events | 5 / 15 | 1 / 6 |
| serious Total, serious adverse events | 12 / 15 | 4 / 6 |
Outcome results
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 2 months | 12.47 score on a scale | Standard Deviation 4.758 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 6 months | 11.21 score on a scale | Standard Deviation 5.368 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | Post completion of chemoradiation | 16.67 score on a scale | Standard Deviation 7.287 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 9 months | 12.89 score on a scale | Standard Deviation 5.052 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 4 months | 12.47 score on a scale | Standard Deviation 5.845 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 12 months | 12.843 score on a scale | Standard Deviation 5.323 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | Baseline | 19.763 score on a scale | Standard Deviation 13.438 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 12 months | 8.27 score on a scale | Standard Deviation 0 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | Baseline | 16.355 score on a scale | Standard Deviation 11.098 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | Post completion of chemoradiation | 15.914 score on a scale | Standard Deviation 11.118 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 2 months | 14.15 score on a scale | Standard Deviation 8.316 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 4 months | 14.15 score on a scale | Standard Deviation 10.184 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 6 months | 11.21 score on a scale | Standard Deviation 4.158 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 9 months | 8.27 score on a scale | Standard Deviation 0 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | Post completion of chemoradiation | 16.67 score on a scale | Standard Deviation 7.287 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 4 months | 12.47 score on a scale | Standard Deviation 5.845 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 2 months | 12.47 score on a scale | Standard Deviation 4.758 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 6 months | 11.21 score on a scale | Standard Deviation 5.368 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | Baseline | 19.763 score on a scale | Standard Deviation 13.438 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 6 months | 11.21 score on a scale | Standard Deviation 4.158 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | Baseline | 16.355 score on a scale | Standard Deviation 11.098 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | Post completion of chemoradiation | 15.914 score on a scale | Standard Deviation 11.118 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 2 months | 14.15 score on a scale | Standard Deviation 8.316 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | 4 months | 14.15 score on a scale | Standard Deviation 10.184 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | Post completion of chemoradiation | 0.56 score on a scale | Standard Deviation 0.358 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 4 months | 0.802 score on a scale | Standard Deviation 0.287 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 2 months | 0.803 score on a scale | Standard Deviation 0.295 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 6 months | 0.816 score on a scale | Standard Deviation 0.202 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | Baseline | 0.664 score on a scale | Standard Deviation 0.405 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 6 months | 0.942 score on a scale | Standard Deviation 0.083 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | Baseline | 0.486 score on a scale | Standard Deviation 0.496 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | Post completion of chemoradiation | 0.607 score on a scale | Standard Deviation 0.39 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 2 months | 0.818 score on a scale | Standard Deviation 0.124 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 4 months | 0.645 score on a scale | Standard Deviation 0.488 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 2 months | 0.803 score on a scale | Standard Deviation 0.295 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 6 months | 0.816 score on a scale | Standard Deviation 0.202 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | Post completion of chemoradiation | 0.56 score on a scale | Standard Deviation 0.358 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 9 months | 0.863 score on a scale | Standard Deviation 0.161 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 4 months | 0.802 score on a scale | Standard Deviation 0.287 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 12 months | 0.84 score on a scale | Standard Deviation 0.181 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | Baseline | 0.664 score on a scale | Standard Deviation 0.405 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 12 months | 1 score on a scale | Standard Deviation 0 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | Baseline | 0.486 score on a scale | Standard Deviation 0.496 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | Post completion of chemoradiation | 0.607 score on a scale | Standard Deviation 0.39 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 2 months | 0.818 score on a scale | Standard Deviation 0.124 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 4 months | 0.645 score on a scale | Standard Deviation 0.488 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 6 months | 0.942 score on a scale | Standard Deviation 0.083 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | 9 months | 0.734 score on a scale | Standard Deviation 0.377 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | Post completion of chemoradiation | 4.135 score on a scale | Standard Deviation 1.795 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 4 months | 2.429 score on a scale | Standard Deviation 2.107 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 2 months | 1.012 score on a scale | Standard Deviation 1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 6 months | 1 score on a scale | Standard Deviation 0.632 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | Baseline | 1.994 score on a scale | Standard Deviation 1.641 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 6 months | 0.738 score on a scale | Standard Deviation 1.044 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | Baseline | 1.127 score on a scale | Standard Deviation 0.634 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | Post completion of chemoradiation | 3.024 score on a scale | Standard Deviation 2.454 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 2 months | 1.31 score on a scale | Standard Deviation 1.112 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 4 months | 1.714 score on a scale | Standard Deviation 2.603 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 2 months | 1.012 score on a scale | Standard Deviation 1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 6 months | 1 score on a scale | Standard Deviation 0.632 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | Post completion of chemoradiation | 4.135 score on a scale | Standard Deviation 1.795 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 9 months | 0.878 score on a scale | Standard Deviation 0.858 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 4 months | 2.429 score on a scale | Standard Deviation 2.107 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 12 months | 1.224 score on a scale | Standard Deviation 1.319 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | Baseline | 1.994 score on a scale | Standard Deviation 1.641 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 12 months | 0.524 score on a scale | Standard Deviation 0.202 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | Baseline | 1.127 score on a scale | Standard Deviation 0.634 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | Post completion of chemoradiation | 3.024 score on a scale | Standard Deviation 2.454 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 2 months | 1.31 score on a scale | Standard Deviation 1.112 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 4 months | 1.714 score on a scale | Standard Deviation 2.603 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 6 months | 0.738 score on a scale | Standard Deviation 1.044 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | 9 months | 2.476 score on a scale | — |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 2 months | 90.2 score on a scale | Standard Deviation 15.9 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 6 months | 88.2 score on a scale | Standard Deviation 16.8 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | Post completion of chemoradiation | 88.2 score on a scale | Standard Deviation 15.8 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 9 months | 87.5 score on a scale | Standard Deviation 18.8 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 4 months | 88.5 score on a scale | Standard Deviation 25.3 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 12 months | 91.8 score on a scale | Standard Deviation 11.3 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | Baseline | 89.0 score on a scale | Standard Deviation 14.2 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 12 months | 100 score on a scale | Standard Deviation 0 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | Baseline | 71.1 score on a scale | Standard Deviation 25.8 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | Post completion of chemoradiation | 83.4 score on a scale | Standard Deviation 24.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 2 months | 98.4 score on a scale | Standard Deviation 3.3 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 4 months | 84.2 score on a scale | Standard Deviation 27.3 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 6 months | 98.7 score on a scale | Standard Deviation 1.9 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 9 months | 99.3 score on a scale | Standard Deviation 0.9 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | Post completion of chemoradiation | 88.2 score on a scale | Standard Deviation 15.8 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 4 months | 88.5 score on a scale | Standard Deviation 25.3 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 2 months | 90.2 score on a scale | Standard Deviation 15.9 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 6 months | 88.2 score on a scale | Standard Deviation 16.8 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | Baseline | 89 score on a scale | Standard Deviation 14.2 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 6 months | 98.7 score on a scale | Standard Deviation 1.9 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | Baseline | 71.1 score on a scale | Standard Deviation 25.8 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | Post completion of chemoradiation | 83.4 score on a scale | Standard Deviation 24.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 2 months | 98.4 score on a scale | Standard Deviation 3.3 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | 4 months | 84.2 score on a scale | Standard Deviation 27.3 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | 4 months | 2 score on a scale | Standard Deviation 1.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | 9 months | 1.6 score on a scale | Standard Deviation 0.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | 2 months | 2.6 score on a scale | Standard Deviation 1.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | 12 months | 2 score on a scale | Standard Deviation 1.1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | 6 months | 1.9 score on a scale | Standard Deviation 1.1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | Post completion of chemoradiation | 3.1 score on a scale | Standard Deviation 1.2 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | Baseline | 2.1 score on a scale | Standard Deviation 1.3 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | Post completion of chemoradiation | 2 score on a scale | Standard Deviation 1.2 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | Baseline | 2.5 score on a scale | Standard Deviation 1.9 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | 2 months | 1.5 score on a scale | Standard Deviation 1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | 4 months | 1.7 score on a scale | Standard Deviation 1.2 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | 6 months | 1 score on a scale | Standard Deviation 0 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | 9 months | 2 score on a scale | Standard Deviation 1.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | 12 months | 1.5 score on a scale | Standard Deviation 0.7 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | 2 months | 1.7 score on a scale | Standard Deviation 0.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | 6 months | 1.8 score on a scale | Standard Deviation 0.4 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | Post completion of chemoradiation | 1.6 score on a scale | Standard Deviation 0.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | 9 months | 1.6 score on a scale | Standard Deviation 0.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | 4 months | 1.5 score on a scale | Standard Deviation 0.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | 12 months | 1.8 score on a scale | Standard Deviation 0.4 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | Baseline | 1.6 score on a scale | Standard Deviation 0.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | 12 months | 2 score on a scale | Standard Deviation 0 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | Baseline | 1.8 score on a scale | Standard Deviation 0.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | Post completion of chemoradiation | 1.5 score on a scale | Standard Deviation 0.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | 2 months | 1.5 score on a scale | Standard Deviation 0.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | 4 months | 1.3 score on a scale | Standard Deviation 0.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | 6 months | 2 score on a scale | Standard Deviation 0 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | 9 months | 1.5 score on a scale | Standard Deviation 0.6 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | 2 months | 2.5 score on a scale | Standard Deviation 0.8 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | 6 months | 3.1 score on a scale | Standard Deviation 1.1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | Post completion of chemoradiation | 3.1 score on a scale | Standard Deviation 0.9 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | 9 months | 3.1 score on a scale | Standard Deviation 0.9 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | 4 months | 3 score on a scale | Standard Deviation 0.8 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | 12 months | 3.1 score on a scale | Standard Deviation 1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | Baseline | 3 score on a scale | Standard Deviation 1.3 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | 12 months | 2 score on a scale | Standard Deviation 0 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | Baseline | 3.5 score on a scale | Standard Deviation 1.9 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | Post completion of chemoradiation | 2.8 score on a scale | Standard Deviation 1.1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | 2 months | 3.2 score on a scale | Standard Deviation 1.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | 4 months | 3 score on a scale | Standard Deviation 1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | 6 months | 2.5 score on a scale | Standard Deviation 0.7 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | 9 months | 3 score on a scale | Standard Deviation 1.4 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | Post completion of chemoradiation | 45.7 score on a scale | Standard Deviation 9.6 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 4 months | 50.4 score on a scale | Standard Deviation 10.2 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 2 months | 50.9 score on a scale | Standard Deviation 11 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 6 months | 50.8 score on a scale | Standard Deviation 8.2 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | Baseline | 45.0 score on a scale | Standard Deviation 15.1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 6 months | 54.7 score on a scale | Standard Deviation 1.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | Baseline | 44.5 score on a scale | Standard Deviation 16.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | Post completion of chemoradiation | 45.7 score on a scale | Standard Deviation 13 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 2 months | 45.3 score on a scale | Standard Deviation 15.9 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 4 months | 44.6 score on a scale | Standard Deviation 12.3 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 2 months | 50.9 score on a scale | Standard Deviation 11 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 6 months | 50.8 score on a scale | Standard Deviation 8.2 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | Post completion of chemoradiation | 45.7 score on a scale | Standard Deviation 9.6 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 9 months | 48.2 score on a scale | Standard Deviation 8.6 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 4 months | 50.4 score on a scale | Standard Deviation 10.2 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 12 months | 51.6 score on a scale | Standard Deviation 7.9 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | Baseline | 45.0 score on a scale | Standard Deviation 15.1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 12 months | 61.4 score on a scale | Standard Deviation 5.3 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | Baseline | 44.5 score on a scale | Standard Deviation 16.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | Post completion of chemoradiation | 45.7 score on a scale | Standard Deviation 13 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 2 months | 45.3 score on a scale | Standard Deviation 15.9 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 4 months | 44.6 score on a scale | Standard Deviation 12.3 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 6 months | 54.7 score on a scale | Standard Deviation 1.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | 9 months | 47.9 score on a scale | Standard Deviation 16 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | 2 months | 2.1 score on a scale | Standard Deviation 1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | 6 months | 2.1 score on a scale | Standard Deviation 1.4 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | Post completion of chemoradiation | 2.9 score on a scale | Standard Deviation 1.1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | 9 months | 2.5 score on a scale | Standard Deviation 1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | 4 months | 1.9 score on a scale | Standard Deviation 0.9 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | 12 months | 2.1 score on a scale | Standard Deviation 1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | Baseline | 2.8 score on a scale | Standard Deviation 1.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | 12 months | 1.5 score on a scale | Standard Deviation 0.6 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | Baseline | 2.8 score on a scale | Standard Deviation 1.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | Post completion of chemoradiation | 2.7 score on a scale | Standard Deviation 1.3 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | 2 months | 2.6 score on a scale | Standard Deviation 1.6 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | 4 months | 2.5 score on a scale | Standard Deviation 1.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | 6 months | 2.2 score on a scale | Standard Deviation 1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | 9 months | 2.8 score on a scale | Standard Deviation 2.2 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 2 months | 40.4 score on a scale | Standard Deviation 12 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 6 months | 42.3 score on a scale | Standard Deviation 12 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | Post completion of chemoradiation | 33.5 score on a scale | Standard Deviation 10.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 9 months | 43.9 score on a scale | Standard Deviation 9.8 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 4 months | 42.6 score on a scale | Standard Deviation 13.3 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 12 months | 42.1 score on a scale | Standard Deviation 11.1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | Baseline | 45.8 score on a scale | Standard Deviation 12.6 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 12 months | 39.8 score on a scale | Standard Deviation 7.2 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | Baseline | 41.9 score on a scale | Standard Deviation 18.1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | Post completion of chemoradiation | 37.6 score on a scale | Standard Deviation 11.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 2 months | 39.4 score on a scale | Standard Deviation 12.6 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 4 months | 42.9 score on a scale | Standard Deviation 14.2 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 6 months | 51.9 score on a scale | Standard Deviation 6.1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 9 months | 40.4 score on a scale | Standard Deviation 17.6 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | Post completion of chemoradiation | 33.5 score on a scale | Standard Deviation 10.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 4 months | 42.6 score on a scale | Standard Deviation 13.3 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 2 months | 40.4 score on a scale | Standard Deviation 12 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 6 months | 42.3 score on a scale | Standard Deviation 12 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | Baseline | 45.8 score on a scale | Standard Deviation 12.6 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 6 months | 51.9 score on a scale | Standard Deviation 6.1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | Baseline | 41.9 score on a scale | Standard Deviation 18.1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | Post completion of chemoradiation | 37.6 score on a scale | Standard Deviation 11.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 2 months | 39.4 score on a scale | Standard Deviation 12.6 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | 4 months | 42.9 score on a scale | Standard Deviation 14.2 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | 2 months | 2.1 score on a scale | Standard Deviation 0.8 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | 6 months | 2.4 score on a scale | Standard Deviation 0.6 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | Post completion of chemoradiation | 1.9 score on a scale | Standard Deviation 0.6 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | 9 months | 2.3 score on a scale | Standard Deviation 0.6 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | 4 months | 2.2 score on a scale | Standard Deviation 0.7 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | 12 months | 2.4 score on a scale | Standard Deviation 0.8 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | Baseline | 2.6 score on a scale | Standard Deviation 0.7 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | 12 months | 1.8 score on a scale | Standard Deviation 0.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | Baseline | 2.6 score on a scale | Standard Deviation 0.7 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | Post completion of chemoradiation | 1.7 score on a scale | Standard Deviation 0.8 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | 2 months | 1.9 score on a scale | Standard Deviation 0.8 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | 4 months | 2.2 score on a scale | Standard Deviation 1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | 6 months | 2.5 score on a scale | Standard Deviation 1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | 9 months | 1.8 score on a scale | Standard Deviation 1 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | 2 months | 1.5 score on a scale | Standard Deviation 0.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | 6 months | 1.5 score on a scale | Standard Deviation 0.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | 9 months | 1.5 score on a scale | Standard Deviation 0.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | Post completion of chemoradiation | 1.1 score on a scale | Standard Deviation 0.4 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | 12 months | 1.5 score on a scale | Standard Deviation 0.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | 4 months | 1.5 score on a scale | Standard Deviation 0.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | Baseline | 1.5 score on a scale | Standard Deviation 0.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | 6 months | 2 score on a scale | Standard Deviation 0 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | Baseline | 1.5 score on a scale | Standard Deviation 0.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | Post completion of chemoradiation | 1.3 score on a scale | Standard Deviation 0.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | 2 months | 1.2 score on a scale | Standard Deviation 0.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | 4 months | 1.3 score on a scale | Standard Deviation 0.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | 9 months | 1.5 score on a scale | Standard Deviation 0.6 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | 12 months | 1.5 score on a scale | Standard Deviation 0.6 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | 2 months | 3.6 score on a scale | Standard Deviation 1.4 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | 6 months | 4 score on a scale | Standard Deviation 1.2 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | Post completion of chemoradiation | 2.9 score on a scale | Standard Deviation 1.3 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | 9 months | 3.9 score on a scale | Standard Deviation 1.3 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | 4 months | 4.3 score on a scale | Standard Deviation 1.3 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | 12 months | 4 score on a scale | Standard Deviation 1.1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | Baseline | 3.9 score on a scale | Standard Deviation 1.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | 12 months | 4.5 score on a scale | Standard Deviation 0.7 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | Baseline | 3 score on a scale | Standard Deviation 1.8 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | Post completion of chemoradiation | 3.4 score on a scale | Standard Deviation 1.3 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | 2 months | 3.8 score on a scale | Standard Deviation 1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | 4 months | 3.7 score on a scale | Standard Deviation 1.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | 6 months | 5 score on a scale | Standard Deviation 0 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | 9 months | 4 score on a scale | Standard Deviation 1.4 |
Primary
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
Population: Participants who did not complete the questionnaires are not included in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | 2 months | 3.4 score on a scale | Standard Deviation 1.1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | 6 months | 3.6 score on a scale | Standard Deviation 1.6 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | Post completion of chemoradiation | 4.4 score on a scale | Standard Deviation 1 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | 9 months | 3.1 score on a scale | Standard Deviation 1.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | 12 months | 3.4 score on a scale | Standard Deviation 1.5 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | 4 months | 3.6 score on a scale | Standard Deviation 1.7 |
| Arm 1: Resectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | Baseline | 3.5 score on a scale | Standard Deviation 1.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | 9 months | 3.5 score on a scale | Standard Deviation 2.1 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | Baseline | 4 score on a scale | Standard Deviation 2.3 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | Post completion of chemoradiation | 4.4 score on a scale | Standard Deviation 1.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | 2 months | 4.2 score on a scale | Standard Deviation 1.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | 4 months | 3.7 score on a scale | Standard Deviation 1.5 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | 6 months | 3 score on a scale | Standard Deviation 1.4 |
| Arm 2: Unresectable (Proton Beam Therapy) | Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | 12 months | 3 score on a scale | Standard Deviation 1.4 |
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Resectable (Proton Beam Therapy) | Physician-reported Toxicity of PBT for Esophageal Cancer | 2 Participants |
| Arm 2: Unresectable (Proton Beam Therapy) | Physician-reported Toxicity of PBT for Esophageal Cancer | 0 Participants |
Secondary
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)
Secondary
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)