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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Resectable (proton beam therapy) | Experimental |
|
|
| Arm 2: Unresectable (proton beam therapy) | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton beam therapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | The EQ-5D is a standardized 2-part, patient-administered instrument used for direct and indirect assessment of health state utilities. The first part asks respondents to "check the ONE box [next to the appropriate statement] that best describes your health TODAY" for each of 5 health dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state. Both the 5-item index score and the VAS score are transformed into a utility score between 0 "Worst health state" and 1 "Best health state. The higher the score the better health a patient experienced. | Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | The 19-item MOS Social Support Survey was designed for use with patients with chronic diseases and measures how often different kinds of support are available, if needed. Response choices range from "none of the time" (1) to "all of the time" (5). A mean social support score for all 19 items is computed to a 0-100 scale with higher scores indicating a greater availability of social support. | Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years following chemoradiation (estimated to be 5 years and 3 months) |
| Overall Survival (OS)of PBT for Patients With Resectable Versus Unresectable Esophageal |
Not provided
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Vlacich, M.D., Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Resectable (Proton Beam Therapy) |
|
| FG001 | Arm 2: Unresectable (Proton Beam Therapy) |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Resectable (Proton Beam Therapy) |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months |
|
Adverse events are collected from start of treatment through 1 year. All-cause mortality is collected from start of treatment through 5 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Resectable (Proton Beam Therapy) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Vlacich, M.D., Ph.D. | Washington University School of Medicine | 314-362-8610 | gvlacich@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2023 | Aug 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D019538 | Health Care Surveys |
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|
| Patient-Reported Outcome Measures | Other | -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 |
|
|
| 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. | Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus | The MDASI-Plus is a reliable, validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis. Patients are asked to fill out a twenty-seven question inventory. 21 questions ask the patient about the severity of their symptoms with answers ranging from 0=not present to 10=as bad as you can imagine. 6 questions ask the patient about how their symptoms interfered with their life with answers ranging from 0=did not interfere to 10=interfered completely. The higher the score the more severe symptom experience the patient experienced. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire | The EQ-5D is a standardized 2-part, patient-administered instrument used for direct and indirect assessment of health state utilities. The first part asks respondents to "check the ONE box [next to the appropriate statement] that best describes your health TODAY" for each of 5 health dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state. Both the 5-item index score and the VAS score are transformed into a utility score between 0 "Worst health state" and 1 "Best health state. The higher the score the better health a patient experienced. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey | The 19-item MOS Social Support Survey was designed for use with patients with chronic diseases and measures how often different kinds of support are available, if needed. Response choices range from "none of the time" (1) to "all of the time" (5). A mean social support score for all 19 items is computed to a 0-100 scale with higher scores indicating a greater availability of social support. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D) | The CES-D questionnaire is a 20-item measure which evaluates depressive symptoms. This trial will make use of the validated 4-item screening version in order to reduce participant burden. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Physician-reported Toxicity of PBT for Esophageal Cancer | Number of participants with grade 3 or higher specific cardiac, metabolism/nutrition, gastrointestinal, respiratory/thoracic/mediastinal, and skin/subcutaneous toxicity using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 related to PBT | Through 6 months following chemoradiation (estimated to be 9 months) |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life. MCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. MCS range is 40-65. | Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life. PCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. PCS range is 30-55. | Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score | The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life. PCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. PCS range is 30-55. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score | The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life. MCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. MCS range is 40-65. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score | The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score | The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-3. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score | The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-2. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score | The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-2. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score | The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score | The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-6. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score | The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-6. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score | The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5. | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
| 5 years following chemoradiation (estimated to be 5 years and 3 months) |
| BG001 | Arm 2: Unresectable (Proton Beam Therapy) |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| OG001 | Arm 2: Unresectable (Proton Beam Therapy) |
|
|
|
| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months |
|
|
|
| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months |
|
|
|
| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months |
|
|
|
| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
|
|
|
| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
|
|
|
| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
|
|
|
| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | Through 6 months following chemoradiation (estimated to be 9 months) |
|
|
|
| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months |
|
|
|
| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months |
|
|
|
| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 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. | Not Posted | Aug 2027 | 5 years following chemoradiation (estimated to be 5 years and 3 months) | Participants |
| Secondary | Overall Survival (OS)of PBT for Patients With Resectable Versus Unresectable Esophageal | Not Posted | Aug 2027 | 5 years following chemoradiation (estimated to be 5 years and 3 months) | Participants |
| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
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| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
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| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
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| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
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| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
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| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
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| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
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| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
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| 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. | Participants who did not complete the questionnaires are not included in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months |
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| 8 |
| 15 |
| 12 |
| 15 |
| 5 |
| 15 |
| EG001 | Arm 2: Unresectable (Proton Beam Therapy) |
| 4 | 6 | 4 | 6 | 1 | 6 |
| Atrioventricular block first degree | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Chest pain-cardiac | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Heart failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Pericardial tamponade | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| COVID-19 infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| ACE induced cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pulmonary artery pseudoaneurysm | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Cellulitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Gastric stenosis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hepatitis viral | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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Not provided
Not provided
Not provided
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D011795 |
| Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Post completion of chemoradiation |
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| 2 months |
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| 4 months |
|
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| 6 months |
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| Post completion of chemoradiation |
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| Post completion of chemoradiation |
|
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| 2 months |
|
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| 4 months |
|
|
| 6 months |
|
|
| Post completion of chemoradiation |
|
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| 2 months |
|
|
| 4 months |
|
|
| 6 months |
|
|
| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
|
|
| 2 months |
|
|
| 4 months |
|
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| 6 months |
|
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| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
|
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
|
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
|
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| Post completion of chemoradiation |
|
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| Post completion of chemoradiation |
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
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| 2 months |
|
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| 4 months |
|
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| 6 months |
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| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
|
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
|
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
|
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
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| 2 months |
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| 4 months |
|
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| 6 months |
|
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| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| 9 months |
|
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| 12 months |
|
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| Post completion of chemoradiation |
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| 2 months |
|
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| 4 months |
|
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| 6 months |
|
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| 9 months |
|
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| 12 months |
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