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Stereotactic ablative radiotherapy for the comprehensive treatment of 4–10 oligometastatic tumors (SABR-COMET-10): study protocol for a randomized phase III trial

study protocol for a randomized phase III trial
Authors: Palma, David A.; Olson, Robert; Harrow, Stephen; Correa, Rohann J.M.; Schneiders, Famke; Haasbeek, Cornelis J.A.; Rodrigues, George B.; +18 Authors

Stereotactic ablative radiotherapy for the comprehensive treatment of 4–10 oligometastatic tumors (SABR-COMET-10): study protocol for a randomized phase III trial

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. Trial registration Clinicaltrials.gov identifier: NCT03721341. Date of registration: October 26, 2018. Electronic supplementary material The online version of this article (10.1186/s12885-019-5977-6) contains supplementary material, which is available to authorized users.

Countries
Netherlands, Canada
Subjects by Vocabulary

Library of Congress Subject Headings: lcsh:RC254-282 lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens

Keywords

Male, Quality of life, Cancer Research, Survival, Radiosurgery, Study Protocol, Neoplasms, Surveys and Questionnaires, Biomarkers, Tumor, Stereotactic radiotherapy, Genetics, Humans, RC254-282, Cancer, Patient Selection, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Neoplastic Cells, Circulating, Prognosis, Magnetic Resonance Imaging, Progression-Free Survival, Tumor Burden, Oncology, Female, Dose Fractionation, Radiation, Tomography, X-Ray Computed, Oligometastases, Follow-Up Studies

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Palma, DA, Olson, RA, Harrow, S, Gaede, S, Louie, AV, Haasbeek, C, Mulroy, LA, Lock, MI, Rodrigues, G, Yaremko, BP. Stereotactic Ablative Radiation Therapy for the Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): Results of a Randomized Trial. Int J Radiat Oncol Biol Physics. 2018; 102 (3): S3-S4 [OpenAIRE] [DOI]

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citations
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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