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Published on: May 8, 2018
Population-based phase II trial of stereotactic ablative radiotherapy (SABR) for up to 5 oligometastases: SABR-5
Robert Olson1,2,3, Mitchell Liu4,5, Alanah Bergman5
1University of British Columbia, Vancouver, Canada. rolson2@bccancer.bc.ca.
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.
Insights
This study assesses the toxicity of stereotactic ablative radiotherapy (SABR) for oligometastases, a limited cancer spread state. Findings will inform the safe use of SABR outside of clinical trials.
Area of Science:
- Oncology
- Radiation Oncology
- Clinical Trials
Background:
- Oligometastases represent a limited stage of cancer spread (1-5 metastases).
- Stereotactic ablative radiotherapy (SABR) is an emerging treatment for oligometastases.
- There is a need for prospective toxicity data for SABR in oligometastatic disease.
Purpose of the Study:
- To evaluate the toxicity of SABR in patients with oligometastatic cancer.
- To provide population-based toxicity estimates for SABR treatment.
- To inform the off-trial use of SABR.
Main Methods:
- A non-randomized, phase II clinical trial.
- 200 patients with newly diagnosed or progressing oligometastatic disease will receive SABR.
- The study is powered to estimate the risk of late grade 4 toxicity with 95% confidence.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- SABR is increasingly used for oligometastases off-trial without sufficient toxicity data.
- This trial will yield crucial toxicity data for SABR in a population-based cohort.
- Results will complement ongoing efficacy data from phase III trials.
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