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Single vs. Multiple Fraction Trial of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastases/Progression
Sponsor: Robert Olson
Summary
Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques, while trying to avoid healthy tissues and organs. However, SABR treatment requires increased planning, treatment time, cost and potential for higher toxicity due to the higher dose. The purpose of this study is to compare single fraction (SF) SABR vs. multiple fraction (MF) SABR in regards to toxicities, progression-free survival, quality of life (QoL), and cost-effectiveness. In a subset of patients, we will also compare patient QoL, hospitalization rates, and cost-effectiveness between patients who complete QoL questionnaires, record symptoms and receive healthcare provider-guided intervention vs. patients who complete QoL questionnaires only.
Official title: Single vs. Multiple Fraction Non-Inferiority Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligo-metastases/Progression: SIMPLIFY-SABR-COMET
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
598
Start Date
2025-04-16
Completion Date
2035-05-30
Last Updated
2026-03-11
Healthy Volunteers
No
Interventions
Single fraction SABR
Participants randomized to this arm will receive SF SABR Treatment recommendations are as follows: Lung: Greater than 2 cm from mediastinum or brachial plexus or if mandatory OAR constraints are met: 30 Gy in 1 fraction Lung: Within 2 cm of mediastinum or brachial plexus 20 Gy in 1 fraction Bone, Spine, Adrenal, lymph node/soft tissue: 20 Gy in 1 fraction Liver: 30 Gy in 1 fraction Brain: dose as per institutional policy
Multiple fraction SABR
Participants randomized to this arm will receive MF SABR: Dose/Fractionation are as follows: Lung: Greater than 2 cm from mediastinum or brachial plexus or if mandatory organ-at-risk (OAR) constraints are met: 48 Gy in 4 fractions (12 Gy/#), 54 Gy in 3 fractions (18 Gy/#), daily or every second day Lung: Within 2 cm of mediastinum or brachial plexus 60 Gy in 8 fractions (7.5 Gy/#), 50 Gy in 5 fractions (10 Gy/#), daily Bone: Any bone except spine: 35 Gy in 5 fractions (7 Gy/#), daily Liver: 54 Gy in 3 fractions (18 Gy/#) or 5 fractions (10.8 Gy/#), daily or every second day Spine: 24 Gy in 2 fractions (12 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily Adrenal: 40 Gy in 5 fractions (8 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily Lymph node/soft tissue: 40 Gy in 5 fractions (8 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily Brain - dose per institutional policy for stereotactic lesions (no whole brain RT).
QoL reporting alone
Participants randomized to this arm will complete the EQ-5D-5L and FACT-G at baseline and each follow-up visit
QoL reporting, symptom screen and healthcare provider intervention
Participants randomized to this arm will complete the FACT,G, EQ-5D-5L, radiation-symptom screen and receive healthcare provider-guided intervention based on their symptom reports.
Locations (13)
BC Cancer
Kelowna, British Columbia, Canada
BC Cancer
Prince George, British Columbia, Canada
BC Cancer
Surrey, British Columbia, Canada
BC Cancer
Vancouver, British Columbia, Canada
BC Cancer - Victoria
Victoria, British Columbia, Canada
Princess Margaret Cancer Centre | University Health Network
Toronto, Ontario, Canada
University Hospital Galway
Galway, Connacht, Ireland
St. Luke's Radiation Oncology Network
Dublin, Dublin, Ireland
Mater Private Hospital
Dublin, Leinster, Ireland
Beacon Hospital
Dublin, Leinster, Ireland
Cork University Hospital
Cork, Munster, Ireland
Bon Secours Radiotherapy Cork in Partnership with UPMC Hillman Cancer Centre
Cork, Munster, Ireland
UPMC Whitfield Hospital - Waterford
Waterford, Munster, Ireland