This is a phase II/III international multicentre randomized trial. Patients will be randomized in a 1:2 ratio between the standard of care (Arm 1) and SABR (Arm 2) to all sites of disease. The study will start as a phase II trial with an opportunity to convert to a phase III trial. The objective of this trial is to determine the impact of SABR on overall survival, progression-free survival, quality of life, and toxicity in patients with polymetastatic disease.
Age 18 or older
willing and able to provide informed consent
ECOG performance status 0-2
Life expectancy > or equal to 6 months
Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Chrohn's disease in patients where the GI tract will receive radiotherapy, ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.
For patients with liver metastases, moderate/severe liver dysfunction (Child-Pugh B or C)
Substantial overlap with a previously treated radiation volume. Prior radiotherapy is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biologically effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. All such cases must be discussed with the study PI.
Inability to treat all sites of disease. Any brain metastasis >3 cm in size or a total volume of brain metastases greater than 30 cc.
Parallel
Arm 2: SABR
RadiationSABR to all tumors 6 Gy x 5 over three weeks
Arm 1: Standard of Care
RadiationStandard of care palliative radiotherapy
Overall Survival
Defined as the time form randomization to death from any cause.
Progression-free survival
Defined as the time from randomization to disease progression at any site or death.
Quality of life- An individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
Measured using the Functional Assessment of Cancer Therapy: General (FACT-G)
Quality of life- An individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
Measured using the Functional Assessment of Cancer Therapy: EQ-5D-5L
Toxicity of Ablative Radiotherapy
Will be assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5 for each relevant organ site treated.
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