A randomized phase III trial of stereotactic ablative radiotherapy for patients with up to 10 oligometastases and a synchronous primary tumor (SABR-SYNC): study protocol.

Emerging randomized data, mostly from phase II trials, have suggested that patients with oligometastatic cancers may benefit from ablative treatments such as stereotactic ablative radiotherapy (SABR). However, phase III data testing this paradigm are lacking, and many studies have examined SABR in the setting of metachronous oligometastatic disease. The goal of the SABR-SYNC trial is to assess the effect of SABR in patients with oligometastatic cancers and a synchronous primary tumor. One hundred and eighty patients will be randomized in a 1:2 ratio between standard of care (SOC) palliative-intent treatments vs. SOC + ablative therapy (SABR preferred) to all sites of known disease. Randomization will be stratified based on histology and number of metastases at enrollment. SABR may be delivered in 1-, 3- and 5-fraction regimens, with recommended doses of 20 Gy, 30 Gy, and 35 Gy, respectively. Non-SABR local modalities (e.g. surgery, thermal ablation, conventional radiation) may be used for treatment of the primary or metastases at the discretion of the treating physicians, if those modalities are clinically preferred. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, time to development of new metastatic lesions, time to initiation of next systemic therapy, quality of life, and toxicity. Translational endpoints include assessment of circulating tumor DNA and immunological predictors of outcomes. SABR-SYNC will provide phase III data to assess the impact of SABR on overall survival in a population of patients with synchronous oligometastases. The translational component will attempt to identify novel prognostic and predictive biomarkers to aid in clinical decision making. Clinicaltrials.gov NCT05717166 (registration date: Feb. 8, 2023).

Palma DA ，Giuliani ME ，Correa RJM ，Schneiders FL ，Harrow S ，Guckenberger M ，Zhang T ，Bahig H ，Senthi S ，Chung P ，Olson R ，Lock M ，Raman S ，Bauman GS ，Lok BH ，Laba JM ，Glicksman RM ，Nguyen TK ，Lang P ，Helou J ，Goodman CD ，Mendez LC ，van Rossum PSN ，Warner A ，Gaede S ，Allan AL ... -  《BMC Palliative Care》

Stereotactic ablative radiotherapy for the comprehensive treatment of 1-3 Oligometastatic tumors (SABR-COMET-3): study protocol for a randomized phase III trial.

Olson R ，Mathews L ，Liu M ，Schellenberg D ，Mou B ，Berrang T ，Harrow S ，Correa RJM ，Bhat V ，Pai H ，Mohamed I ，Miller S ，Schneiders F ，Laba J ，Wilke D ，Senthi S ，Louie AV ，Swaminath A ，Chalmers A ，Gaede S ，Warner A ，de Gruijl TD ，Allan A ，Palma DA ... -  《BMC CANCER》

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

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 ... -  《BMC CANCER》

A phase II randomized trial of RAdium-223 dichloride and SABR Versus SABR for oligomEtastatic prostate caNcerS (RAVENS).

Hasan H ，Deek MP ，Phillips R ，Hobbs RF ，Malek R ，Radwan N ，Kiess AP ，Dipasquale S ，Huang J ，Caldwell T ，Leitzel J ，Wendler D ，Wang H ，Thompson E ，Powell J ，Dudley S ，Deville C ，Greco SC ，Song DY ，DeWeese TL ，Gorin MA ，Rowe SP ，Denmeade S ，Markowski M ，Antonarakis ES ，Carducci MA ，Eisenberger MA ，Pomper MG ，Pienta KJ ，Paller CJ ，Tran PT ... -  《BMC CANCER》

Population-based phase II trial of stereotactic ablative radiotherapy (SABR) for up to 5 oligometastases: SABR-5.

Olson R ，Liu M ，Bergman A ，Lam S ，Hsu F ，Mou B ，Berrang T ，Mestrovic A ，Chng N ，Hyde D ，Matthews Q ，Lund C ，Glick D ，Pai H ，Basran P ，Carolan H ，Valev B ，Lefresene S ，Tyldesley S ，Schellenberg D ... -  《BMC CANCER》