TY - JOUR
T1 - Stereotactic ablative radiotherapy for the comprehensive treatment of 1-3 Oligometastatic tumors (SABR-COMET-3)
T2 - Study protocol for a randomized phase III trial
AU - Olson, Robert
AU - Mathews, Lindsay
AU - Liu, Mitchell
AU - Schellenberg, Devin
AU - Mou, Benjamin
AU - Berrang, Tanya
AU - Harrow, Stephen
AU - Correa, Rohann J.M.
AU - Bhat, Vasudeva
AU - Pai, Howard
AU - Mohamed, Islam
AU - Miller, Stacy
AU - Schneiders, Famke
AU - Laba, Joanna
AU - Wilke, Derek
AU - Senthi, Sashendra
AU - Louie, Alexander V.
AU - Swaminath, Anand
AU - Chalmers, Anthony
AU - Gaede, Stewart
AU - Warner, Andrew
AU - De Gruijl, Tanja D.
AU - Allan, Alison
AU - Palma, David A.
PY - 2020/5/5
Y1 - 2020/5/5
N2 - Background: A recent randomized phase II trial evaluated stereotactic ablative radiotherapy (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 a significant improvement in progression-free survival and a trend to an overall survival benefit, supporting progression to phase III randomized trials. Methods: Two hundred and ninety-seven patients will be randomized in a 1:2 ratio between the control arm (consisting of standard of care [SOC] palliative-intent treatments), and the SABR arm (consisting of SOC treatment + SABR to all sites of known disease). Randomization will be stratified by two factors: histology (prostate, breast, or renal vs. all others), and disease-free interval (defined as time from diagnosis of primary tumor until first detection of the metastases being treated on this trial; divided as ≤2 vs. > 2 years). The primary endpoint is overall survival, and secondary endpoints include progression-free survival, cost effectiveness, time to development of new metastatic lesions, quality of life (QoL), 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 survival, QoL, and cost effectiveness to determine if long-term survival can be achieved for selected patients with 1-3 oligometastatic lesions. Trial registration: Clinicaltrials.gov identifier: NCT03862911. Date of registration: March 5, 2019,
AB - Background: A recent randomized phase II trial evaluated stereotactic ablative radiotherapy (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 a significant improvement in progression-free survival and a trend to an overall survival benefit, supporting progression to phase III randomized trials. Methods: Two hundred and ninety-seven patients will be randomized in a 1:2 ratio between the control arm (consisting of standard of care [SOC] palliative-intent treatments), and the SABR arm (consisting of SOC treatment + SABR to all sites of known disease). Randomization will be stratified by two factors: histology (prostate, breast, or renal vs. all others), and disease-free interval (defined as time from diagnosis of primary tumor until first detection of the metastases being treated on this trial; divided as ≤2 vs. > 2 years). The primary endpoint is overall survival, and secondary endpoints include progression-free survival, cost effectiveness, time to development of new metastatic lesions, quality of life (QoL), 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 survival, QoL, and cost effectiveness to determine if long-term survival can be achieved for selected patients with 1-3 oligometastatic lesions. Trial registration: Clinicaltrials.gov identifier: NCT03862911. Date of registration: March 5, 2019,
KW - Cancer
KW - Oligometastases
KW - Quality of life
KW - Stereotactic radiotherapy
KW - Survival
UR - http://www.scopus.com/inward/record.url?scp=85084327673&partnerID=8YFLogxK
U2 - 10.1186/s12885-020-06876-4
DO - 10.1186/s12885-020-06876-4
M3 - Article
C2 - 32370765
AN - SCOPUS:85084327673
VL - 20
JO - BMC Cancer
JF - BMC Cancer
SN - 1471-2407
IS - 1
M1 - 380
ER -
