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Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic (1-3 Metastases) Cancer
Sponsor: British Columbia Cancer Agency
Summary
Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques. SABR is non-invasive and delivered on an outpatient basis. The purpose of this study is to compare the effect of SABR, relative to standard of care (SOC) alone, on overall survival, progression-free survival, toxicity, and quality of life. An integrated economic evaluation will determine the cost per quality of life year gained using SABR (vs. SOC) and a translational component will enable identification of predictive/prognostic biomarkers of the oligometastatic state.
Official title: Phase III Randomized Controlled Trial and Economic Evaluation of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic (1-3 Metastases) Cancer (SABR-COMET-3)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
330
Start Date
2019-11-01
Completion Date
2030-12-31
Last Updated
2025-11-28
Healthy Volunteers
No
Conditions
Interventions
palliative radiotherapy
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. Patients in this arm should not receive stereotactic doses or radiotherapy boosts. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.
Stereotactic ablative radiotherapy
Lung: Tumors 5 cm or less surrounded by lung parenchyma 48 Gy/4#, or 54 Gy/3#, daily or every second day Within 2 cm of mediastinum or brachial plexus 60 Gy/8#, daily Bone: Any bone 35 Gy/5#, or 24 Gy/2#, daily Brain: Stereotactic lesions (no whole brain RT) \<2cm 20-24 Gy/1#, once 2-3 cm 18 Gy/1#, once Metastases only: 35Gy/5# to PTV, daily Whole brain + Mets: 35Gy to metastases, daily 20 Gy whole brain, daily Liver: 54 Gy/3#, every second day Adrenal/Pancreas: 40 Gy/5# / 35Gy/7#, daily Lymph Node: 40 Gy/5#, daily
Locations (17)
Cancer Care Griffith
Griffith, New South Wales, Australia
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
BC Cancer
Kelowna, British Columbia, Canada
BC Cancer - Prince George
Prince George, British Columbia, Canada
BC Cancer
Surrey, British Columbia, Canada
BC Cancer
Vancouver, British Columbia, Canada
BC Cancer
Victoria, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
Walker Family Cancer Centre
Saint Catharines, Ontario, Canada
St. Luke's Radiation Oncology Network
Rathgar, Dublin, Ireland
Beacon Hospital
Dublin, Sandyford, Ireland
Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre
Cork, Ireland
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Edinburgh Cancer Centre
Edinburgh, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom