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

David A. Palma, Robert Olson, Stephen Harrow, Rohann J. M. Correa, Famke Schneiders, Cornelis J. A. Haasbeek, George B. Rodrigues, Michael Lock, Brian P. Yaremko, Glenn S. Bauman, Belal Ahmad, Devin Schellenberg, Mitchell Liu, Stewart Gaede, Joanna Laba, Liam Mulroy, Sashendra Senthi, Alexander V. Louie, Anand Swaminath, Anthony Chalmers & 5 others Andrew Warner, Ben J. Slotman, Tanja D. de Gruijl, Alison Allan, Suresh Senan

Research output: Contribution to journalArticleAcademicpeer-review

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.
Original languageEnglish
Article number816
JournalBMC Cancer
Volume19
Issue number1
DOIs
Publication statusPublished - 2019

Cite this

Palma, David A. ; Olson, Robert ; Harrow, Stephen ; Correa, Rohann J. M. ; Schneiders, Famke ; Haasbeek, Cornelis J. A. ; Rodrigues, George B. ; Lock, Michael ; Yaremko, Brian P. ; Bauman, Glenn S. ; Ahmad, Belal ; Schellenberg, Devin ; Liu, Mitchell ; Gaede, Stewart ; Laba, Joanna ; Mulroy, Liam ; Senthi, Sashendra ; Louie, Alexander V. ; Swaminath, Anand ; Chalmers, Anthony ; Warner, Andrew ; Slotman, Ben J. ; de Gruijl, Tanja D. ; Allan, Alison ; Senan, Suresh. / Stereotactic ablative radiotherapy for the comprehensive treatment of 4-10 oligometastatic tumors (SABR-COMET-10) : study protocol for a randomized phase III trial. In: BMC Cancer. 2019 ; Vol. 19, No. 1.
@article{080f956efbc54f07b9f7e0277454bcdf,
title = "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.",
author = "Palma, {David A.} and Robert Olson and Stephen Harrow and Correa, {Rohann J. M.} and Famke Schneiders and Haasbeek, {Cornelis J. A.} and Rodrigues, {George B.} and Michael Lock and Yaremko, {Brian P.} and Bauman, {Glenn S.} and Belal Ahmad and Devin Schellenberg and Mitchell Liu and Stewart Gaede and Joanna Laba and Liam Mulroy and Sashendra Senthi and Louie, {Alexander V.} and Anand Swaminath and Anthony Chalmers and Andrew Warner and Slotman, {Ben J.} and {de Gruijl}, {Tanja D.} and Alison Allan and Suresh Senan",
year = "2019",
doi = "10.1186/s12885-019-5977-6",
language = "English",
volume = "19",
journal = "BMC Cancer",
issn = "1471-2407",
publisher = "BioMed Central",
number = "1",

}

Palma, DA, Olson, R, Harrow, S, Correa, RJM, Schneiders, F, Haasbeek, CJA, Rodrigues, GB, Lock, M, Yaremko, BP, Bauman, GS, Ahmad, B, Schellenberg, D, Liu, M, Gaede, S, Laba, J, Mulroy, L, Senthi, S, Louie, AV, Swaminath, A, Chalmers, A, Warner, A, Slotman, BJ, de Gruijl, TD, Allan, A & Senan, S 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, vol. 19, no. 1, 816. https://doi.org/10.1186/s12885-019-5977-6, https://doi.org/10.1186/s12885-019-5977-6

Stereotactic ablative radiotherapy for the comprehensive treatment of 4-10 oligometastatic tumors (SABR-COMET-10) : study protocol for a randomized phase III trial. / Palma, David A.; Olson, Robert; Harrow, Stephen; Correa, Rohann J. M.; Schneiders, Famke; Haasbeek, Cornelis J. A.; Rodrigues, George B.; Lock, Michael; Yaremko, Brian P.; Bauman, Glenn S.; Ahmad, Belal; Schellenberg, Devin; Liu, Mitchell; Gaede, Stewart; Laba, Joanna; Mulroy, Liam; Senthi, Sashendra; Louie, Alexander V.; Swaminath, Anand; Chalmers, Anthony; Warner, Andrew; Slotman, Ben J.; de Gruijl, Tanja D.; Allan, Alison; Senan, Suresh.

In: BMC Cancer, Vol. 19, No. 1, 816, 2019.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Stereotactic ablative radiotherapy for the comprehensive treatment of 4-10 oligometastatic tumors (SABR-COMET-10)

T2 - study protocol for a randomized phase III trial

AU - Palma, David A.

AU - Olson, Robert

AU - Harrow, Stephen

AU - Correa, Rohann J. M.

AU - Schneiders, Famke

AU - Haasbeek, Cornelis J. A.

AU - Rodrigues, George B.

AU - Lock, Michael

AU - Yaremko, Brian P.

AU - Bauman, Glenn S.

AU - Ahmad, Belal

AU - Schellenberg, Devin

AU - Liu, Mitchell

AU - Gaede, Stewart

AU - Laba, Joanna

AU - Mulroy, Liam

AU - Senthi, Sashendra

AU - Louie, Alexander V.

AU - Swaminath, Anand

AU - Chalmers, Anthony

AU - Warner, Andrew

AU - Slotman, Ben J.

AU - de Gruijl, Tanja D.

AU - Allan, Alison

AU - Senan, Suresh

PY - 2019

Y1 - 2019

N2 - 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.

AB - 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.

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U2 - 10.1186/s12885-019-5977-6

DO - 10.1186/s12885-019-5977-6

M3 - Article

VL - 19

JO - BMC Cancer

JF - BMC Cancer

SN - 1471-2407

IS - 1

M1 - 816

ER -