Population-based phase II trial of stereotactic ablative radiotherapy (SABR) for up to 5 oligometastases: SABR-5

Robert Olson, Mitchell Liu, Alanah Bergman, Sonya Lam, Fred Hsu, Benjamin Mou, Tanya Berrang, Ante Mestrovic, Nick Chng, Derek Hyde, Quinn Matthews, Chad Lund, Daniel Glick, Howard Pai, Parminder Basran, Hannah Carolan, Boris Valev, Shilo Lefresene, Scott Tyldesley, Devin Schellenberg, Robert Olson, Mitchell Liu, Alanah Bergman, Sonya Lam, Fred Hsu, Benjamin Mou, Tanya Berrang, Ante Mestrovic, Nick Chng, Derek Hyde, Quinn Matthews, Chad Lund, Daniel Glick, Howard Pai, Parminder Basran, Hannah Carolan, Boris Valev, Shilo Lefresene, Scott Tyldesley, Devin Schellenberg

Abstract

Background: Oligometastases refer to a state of disease where cancer has spread beyond the primary site, but is not yet widely metastatic, often defined as 1-3 or 1-5 metastases in number. Stereotactic ablative radiotherapy (SABR) is an emerging radiotherapy technique to treat oligometastases that require further prospective population-based toxicity estimates.

Methods: This is a non-randomized phase II trial where all participants will receive experimental SABR treatment to all sites of newly diagnosed or progressing oligometastatic disease. We will accrue 200 patients to assess toxicity associated with this experimental treatment. The study was powered to give a 95% confidence on the risk of late grade 4 toxicity, anticipating a < 5% rate of grade 4 toxicity.

Discussion: SABR treatment of oligometastases is occurring off-trial at a high rate, without sufficient evidence of its efficacy or toxicity. This trial will provide necessary toxicity data in a population-based cohort, using standardized doses and organ at risk constraints, while we await data on efficacy from randomized phase III trials.

Trial registration: Registered through clinicaltrials.gov NCT02933242 on October 14, 2016 prospectively before patient accrual.

Keywords: Oligometastases; Radiotherapy; Stereotactic ablative radiotherapy.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the University of British Columbia Research Ethics Board. This manuscript presents Version 5, April 17, 2018. All amendments have been, and will continue to be communicated to all qualified investigators by the Principal Investigator, RO, or his designate, SL. Written consent will be obtained from participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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