Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change from baseline to 6 months following end of chemoradiation in patient-reported outcomes of PBT for esophageal cancer as measured by the 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, ranking their symptoms on a 0 (no problems) to 10 (worst imaginable) scale before treatment, weekly during treatment, and in treatment follow-up. |
6 months following chemoradiation (estimated to be 9 months) |
|
Primary |
Patient-reported outcomes of PBT for esophageal cancer as measured by the EQ-5D |
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. |
6 months following chemoradiation (estimated to be 9 months) |
|
Primary |
Patient-reported outcomes of PBT for esophageal cancer as measured by the SF-12 |
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. |
6 months following chemoradiation (estimated to be 9 months) |
|
Primary |
Patient-reported outcomes of PBT for esophageal cancer as measured by the MOS Social Support |
The 19-item Medical Outcomes Study (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 with higher scores indicating a greater availability of social support. |
6 months following chemoradiation (estimated to be 9 months) |
|
Primary |
Patient-reported outcomes of PBT for esophageal cancer as measured by the 4-Item CES-D |
The Center for Epidemiological Studies Depression Scale (CES-D) 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. |
6 months following chemoradiation (estimated to be 9 months) |
|
Primary |
Patient-reported outcomes of PBT for esophageal cancer as measured by the 4-Item CES-D |
The Center for Epidemiological Studies Depression Scale (CES-D) 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. |
12 months following chemoradiation (estimated to be 15 months) |
|
Primary |
Patient-reported outcomes of PBT for esophageal cancer as measured by the MOS Social |
The 19-item Medical Outcomes Study (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 with higher scores indicating a greater availability of social support. |
12 months following chemoradiation (estimated to be 15 months) |
|
Primary |
Patient-reported outcomes of PBT for esophageal cancer as measured by the SF-12 |
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. |
12 months following chemoradiation (estimated to be 15 months) |
|
Primary |
Patient-reported outcomes of PBT for esophageal cancer as measured by the EQ-5D |
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. |
12 months following chemoradiation (estimated to be 15 months) |
|
Primary |
Change in baseline to 12 months following end of chemoradiation in patient-reported outcomes of PBT for esophageal cancer as measured by the 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, ranking their symptoms on a 0 (no problems) to 10 (worst imaginable) scale before treatment, weekly during treatment, and in treatment follow-up. |
12 months following chemoradiation (estimated to be 15 months) |
|
Primary |
Physician-reported toxicity of PBT for esophageal cancer |
-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 |
6 months following chemoradiation (estimated to be 9 months) |
|
Secondary |
Progression-free survival (PFS) of proton beam therapy (PBT) for patients with resectable versus unresectable esophageal cancer |
-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. |
2 years following chemoradiation (estimated to be 2 years and 3 months) |
|
Secondary |
Overall survival (OS)of PBT for patients with resectable versus unresectable esophageal cancer |
|
2 years following chemoradiation (estimated to be 2 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. |
5 years following chemoradiation (estimated to be 5 years and 3 months) |
|
Secondary |
Overall survival (OS)of PBT for patients with resectable versus unresectable esophageal |
|
5 years following chemoradiation (estimated to be 5 years and 3 months) |
|