This study's goal is to find out if the kind of side effects people experience from radiation is different depending on the schedule of their radiation treatment. Patients will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation. After patients complete radiation treatment, they will follow up with their radiation oncologist.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Radiation therapy given in a 3 fraction schedule (over 3 days). Total dose is 54 Grays.
Radiation therapy given in 5 fractions (over 5 days). Total dose is 60 Grays.
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
RECRUITINGfrequency of grade 3 treatment related toxicities or higher
Toxicities will be assessed using the National Cancer Institute common toxicities criteria version 4.0. The rates of grade 3 or higher adverse events at 1 year will be calculated as the proportion of patients who have any adverse event of interest by the end of year 1 among the total analyzable patients in each arm.
Time frame: 1 year
mean survival time of patients with overall survival
The failure event for overall survival is a death due to any cause. Survival time is measured from the date of randomization to the date of death or last follow up.
Time frame: 3 years
proportion of patients with disease-free survival
The failure event for disease-free survival is defined as death due to any cause, local failure, marginal failure, involved node failure, regional failure, distant metastasis, or second primary.
Time frame: 3 years
proportions of patients with primary tumor control
Marginal failures will be considered events for primary tumor failure. The primary tumor control rate at 1 year will be calculated as the number of patients who do not have a local progression event by the total number of analyzable patients in each arm at 1 year.
Time frame: 3 years
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