Palma, D. A. et al. (2019) Stereotactic ablative radiotherapy for the comprehensive treatment of 4-10 oligometastatic tumors (SABR-COMET-10): study protocol for a randomized phase III trial. BMC Cancer, 19(1), 816. (doi: 10.1186/s12885-019-5977-6) (PMID:31426760) (PMCID:PMC6699121)
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Abstract
Background: Stereotactic ablative radiotherapy (SABR) has emerged as a new treatment option for patients with oligometastatic disease. SABR delivers precise, high-dose, hypofractionated radiotherapy, and achieves excellent rates of local control for primary tumors or metastases. A recent randomized phase II trial evaluated SABR in a group of patients with a small burden of oligometastatic disease (mostly with 1–3 metastatic lesions), and found that SABR was associated with benefits in progression-free survival and overall survival. The goal of this phase III trial is to assess the impact of SABR in patients with 4–10 metastatic cancer lesions. Methods: One hundred and fifty-nine patients will be randomized in a 1:2 ratio between the control arm (consisting of standard of care palliative-intent treatments), and the SABR arm (consisting of standard of care treatment + SABR to all sites of known disease). Randomization will be stratified by two factors: histology (Group 1: prostate, breast, or renal; Group 2: all others), and type of pre-specified systemic therapy (Group 1: immunotherapy/targeted; Group 2: cytotoxic; Group 3: observation). SABR is to be completed within 2 weeks, allowing for rapid initiation of systemic therapy. Recommended SABR doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions, or 35 Gy in 5 fractions, chosen to minimize risks of toxicity. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, time to development of new metastatic lesions, quality of life, and toxicity. Translational endpoints include assessment of circulating tumor cells, cell-free DNA, and tumor tissue as prognostic and predictive markers, including assessment of immunological predictors of response and long-term survival. Discussion: This study will provide an assessment of the impact of SABR on clinical outcomes and quality of life, to determine if long-term survival can be achieved for selected patients with 4–10 oligometastatic lesions.
| Item Type: | Articles |
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| Additional Information: | Funded through philanthropic donations to the London Health Sciences Foundation designated by donors to specifically fund SABR-COMET10, and through grand funding awarded to DAP from the Ontario Institute for Cancer Research. |
| Keywords: | Cancer, oligometastases, quality of life, stereotactic radiotherapy, survival. |
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Chalmers, Professor Anthony |
| Authors: | Palma, D. A., Olson, R., Harrow, S., Correa, R. J.M., Schneiders, F., Haasbeek, C. J.A., Rodrigues, G. B., Lock, M., Yaremko, B. P., Bauman, G. S., Ahmad, B., Schellenberg, D., Liu, M., Gaede, S., Laba, J., Mulroy, L., Senthi, S., Louie, A. V., Swaminath, A., Chalmers, A., Warner, A., Slotman, B. J., de Gruijl, T. D., Allan, A., and Senan, S. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Cancer Sciences |
| Journal Name: | BMC Cancer |
| Publisher: | BioMed Central |
| ISSN: | 1471-2407 |
| ISSN (Online): | 1471-2407 |
| Copyright Holders: | Copyright © 2019 The Authors |
| First Published: | First published in BMC Cancer 19(1):816 |
| Publisher Policy: | Reproduced under a Creative Commons License |
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