Assess progression-free survival and overall survival of proton beam therapy (PBT) for patients with resectable vs. unresectable esophageal cancer, and to assess patient-reported outcomes of PBT for esophageal cancer at 6 months following chemoradiation and physician-reported toxicity of PBT for esophageal cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Washington University School of Medicine
St Louis, Missouri, United States
Progression-free survival
Assess progression-free survival (PFS) of PBT for patients with resectable vs. unresectable esophageal cancer. PFS will be assessed using the Kaplan-Meier estimate.
Time frame: 5 years
Overall survival
Assess overall survival (OS) of PBT for patients with resectable vs. unresectable esophageal cancer. OS will be assessed using the Kaplan-Meier estimate.
Time frame: 5 years
Progression-free survival
Assess progression-free survival (PFS) of PBT for patients with resectable vs. unresectable esophageal cancer. PFS will be assessed using the Kaplan-Meier estimate.
Time frame: 2 years
Overall survival
Assess overall survival (OS) of PBT for patients with resectable vs. unresectable esophageal cancer. OS will be assessed using the Kaplan-Meier estimate.
Time frame: 2 years
Patient-reported outcomes of PBT for esophageal cancer at 12 months following chemoradiation.
We will calculate descriptive statistics (mean, standard deviation, etc.) for all QOL data (EQ-5D, SF-12) in addition to other PROs (depressive symptoms, social support) at each evaluation period. Univariate tests will explore the associations among QOL and PROs using analysis of variance (ANOVA) and Fisher's exact test for correlation. Changes over time in QOL and PROs will be analyzed utilizing repeated-measures modeling techniques (repeated measures analysis of covariance).
Time frame: 1 year
Quality of life
Patient-reported outcomes of proton beam therapy (PBT) for esophageal cancer at 6 months following chemoradiation We will calculate descriptive statistics (mean, standard deviation, etc.) for all QOL data (EQ-5D, SF-12) in addition to other PROs (depressive symptoms, social support) at each evaluation period. Univariate tests will explore the associations among QOL and PROs using analysis of variance (ANOVA) and Fisher's exact test for correlation. Changes over time in QOL and PROs will be analyzed utilizing repeated-measures modeling techniques (repeated measures analysis of covariance).
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Time frame: 6 months
Toxicity
We will compare the proportion of ≥Grade 3 gastrointestinal or pulmonary toxicity events against historical controls utilizing Binomial tests for proportion.
Time frame: 1 year