This study is a phase III multi-institutional randomized trial. Patients will be randomized in a 1:2 ratio between current standard of care treatment (Arm 1) vs. standard of care treatment + SABR (Arm 2) to sites of known disease. Patients will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis3: histology (Group 1: hormone-sensitive prostate cancer, breast, or renal; Group 2: all others), and number of metastases (Group 1: 1-3; Group 2: 4-10).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.
Pre-specified based on the standard of care approach for that patient.
Pre-specified based on the standard of care approach for that patient.
Pre-specified based on the standard of care approach for that patient.
Pre-specified based on the standard of care approach for that patient.
Pre-specified based on the standard of care approach for that patient.
The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board. Preferred doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every second day), and 35 Gy in 5 fractions (daily).
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists. The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board. Because of the convenience in using SABR for all lesions, non-SABR modalities should only be used if they are likely to provide a benefit over SABR.
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists. Tumors in the esophagus, stomach, small intestine or colon should be treated with either fractionated radiation or a lower SABR dose (e.g. 25 Gy in 5 fractions) to minimize the risk of perforation.
BC Cancer - Centre for the North
Prince George, British Columbia, Canada
NOT_YET_RECRUITINGBC Cancer - Vancouver
Vancouver, British Columbia, Canada
RECRUITINGLondon Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada
RECRUITINGCentre Hospitalier de l'Université de Montréal-CHUM
Montreal, Quebec, Canada
RECRUITINGUniversitätsspital Zürich
Zurich, Switzerland
RECRUITINGOverall Survival
Time from randomization to death from any cause, or date of last follow-up, whichever occurs first.
Time frame: Approximately end of year 6 (Study Completion)
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: General (FACT-G).
Time frame: Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: The EuroQol 5-Dimension 5-Level (EQ-5D-5L).
Time frame: Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)
Toxicity assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5 for each organ treated (e.g. liver, lung, bone).
Time frame: Toxicity outcomes to be collected for the first 2 years (Last week of treatment, in 6 weeks, in 3, 6, 12, 18, 24 months)
Time to next systemic therapy
The time from randomization until commencement of any systemic anti-cancer therapy, or date of last follow-up, whichever occurs first.
Time frame: From randomization to year 6 (study completion).
Receipt of additional radiation during follow-up
Will be collected for SABR (as a binary endpoint; yes/no), and non-SABR (yes/no).
Time frame: During year 6 (follow-up year).
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