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ACTIVE NOT RECRUITING
NCT03862911
NA

Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic (1-3 Metastases) Cancer

Sponsor: British Columbia Cancer Agency

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. 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

Interventions

RADIATION

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.

RADIATION

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