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OBJECTIVES
Primary Objective
Compare overall survival (
OS
).The rationale in this trial is to determine if proton therapy can
improve overall survival by reducing the risk of severe toxicity to organs at risk compared to
photon-based IMRT.
Secondary Objectives
➢
To compare 2-year progression-free survival (
PFS)
➢
To compare the development of grade 3 or higher adverse events
➢
To compare differences between the two arms in
QOL
based primarily on the development
of shortness of breath at 6 months, the development of sore throat at the end of
chemoRTas, and breathing related functioning impairments (Shortness ofBreath
Questionnaire [SOBQ])
➢
To compare
cost-effectiveness
outcomes between the 2 arms;
1)
initial therapy costs;
2)
costs of managing side effects as determined by this study
3)
costs of managing recurrence.
➢
To compare pulmonary function changes by treatment arms and response;
➢
To explore the most appropriate and clinically relevant
technological parameters
to
ensure quality and effectiveness throughout radiation therapy processes, including imaging,
simulation, patient immobilization, target and critical structure definition, treatment planning,
image guidance and delivery.
RTOG- 1308 cont..