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Population-based phase II trial of stereotactic ablative radiotherapy (SABR) for up to 5 oligometastases: SABR-5 Olson, Robert; Liu, Mitchell; Bergman, Alanah; Lam, Sonya; Hsu, Fred; Mou, Benjamin; Berrang, Tanya; Mestrovic, Ante; Chng, Nick; Hyde, Derek; Matthews, Quinn; Lund, Chad; Glick, Daniel; Pai, Howard; Basran, Parminder; Carolan, Hannah; Valev, Boris; Lefresene, Shilo; Tyldesley, Scott; Schellenberg, Devin
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.
Item Metadata
Title |
Population-based phase II trial of stereotactic ablative radiotherapy (SABR) for up to 5 oligometastases: SABR-5
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Creator |
Olson, Robert; Liu, Mitchell; Bergman, Alanah; Lam, Sonya; Hsu, Fred; Mou, Benjamin; Berrang, Tanya; Mestrovic, Ante; Chng, Nick; Hyde, Derek; Matthews, Quinn; Lund, Chad; Glick, Daniel; Pai, Howard; Basran, Parminder; Carolan, Hannah; Valev, Boris; Lefresene, Shilo; Tyldesley, Scott; Schellenberg, Devin
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Publisher |
BioMed Central
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Date Issued |
2018-10-04
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Description |
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.
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Subject | |
Genre | |
Type | |
Language |
eng
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Date Available |
2018-10-23
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Provider |
Vancouver : University of British Columbia Library
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Rights |
Attribution 4.0 International (CC BY 4.0)
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DOI |
10.14288/1.0372978
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URI | |
Affiliation | |
Citation |
BMC Cancer. 2018 Oct 04;18(1):954
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Publisher DOI |
10.1186/s12885-018-4859-7
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Peer Review Status |
Reviewed
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Scholarly Level |
Faculty
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Copyright Holder |
The Author(s).
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Rights URI | |
Aggregated Source Repository |
DSpace
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Rights
Attribution 4.0 International (CC BY 4.0)