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RECRUITING
NCT05784428
NA

Single vs. Multiple Fraction Trial of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastases/Progression

Sponsor: Robert Olson

View on ClinicalTrials.gov

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

RADIATION

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

RADIATION

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).

OTHER

QoL reporting alone

Participants randomized to this arm will complete the EQ-5D-5L and FACT-G at baseline and each follow-up visit

OTHER

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