This is a pragmatic trial with patients randomized between standard of care palliative thoracic radiation therapy (RT) vs. hypofractionated, dose-escalated, esophageal-sparing (HD-ES) intensity modulated radiation therapy (IMRT). The investigators hypothesize that the use of advanced radiation planning techniques to optimize dose to esophagus will permit the safe delivery of a modestly dose-escalated five-fraction course of palliative radiation to intrathoracic malignancies. This approach aims to deliver higher biologically effective doses while improving toxicity when compared to conventional approaches with the goal of prolonging high-quality overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
141
Hypofractionated, dose-escalated, esophageal-sparing intensity modulated radiation therapy
standard of care palliative thoracic radiotherapy using volumetric modulated arc therapy/intensity-modulating radiotherapy
British Columbia Cancer Agency Center for the Southern Interior
Kelowna, British Columbia, Canada
RECRUITINGLondon Health Sciences Center Research Institute (Formerly Lawson Research Institute)
London, Ontario, Canada
RECRUITINGWaterloo Regional Health Network
Waterloo, Ontario, Canada
RECRUITINGtime to definitive quality of life deterioration or death
Defined as time from randomization to the first of: i. deterioration in Functional Assessment of Cancer Therapy: Lung Trial Outcome Index score by greater than or equal to 5 points compared to baseline score and with no subsequent improvement to within 5 points of baseline ii. death iii. last follow-up
Time frame: from enrollment until 36 months post radiotherapy
Quality of Life - Patient Reported Outcomes
Measured via Functional Assessment of Cancer Therapy: Lung and EuroQol 5-dimension 5-level
Time frame: From enrollment until 36 months post radiotherapy
Toxicity - Adverse Events that happen to a patient during the clinical trial
Defined as incidence of Common Terminology Criteria for Adverse Events version 5 grade 2 and higher toxicity
Time frame: From enrollment until 36 months post radiotherapy
Freedom from intrathoracic progression
Defined as time from randomization to disease progression within the thorax, or last follow-up, whichever occurs first
Time frame: From enrollment until 36 months post radiotherapy
Overall Survival
Defined as time from randomization to death from any cause, or last follow-up, whichever occurs first
Time frame: From enrollment until 36 months post radiotherapy
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