Journal Article

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

Correa, Rohann J. M., Olson, Robert, Zhang, Tina, Giuliani, Meredith E., Laba, Joanna M., Mendez, Lucas C., Guckenberger, Matthias, Lok, Benjamin H., Harrow, Stephen, Nguyen, Timothy K., Helou, Joelle, Bahig, Houda, Lock, Michael, van Rossum, Peter S. N., Gaede, Stewart, Schneiders, Famke L., Bauman, Glenn S., Glicksman, Rachel M., Palma, David A., Warner, Andrew, Allan, Alison L., Chung, Peter, Raman, Srinivas, Lang, Pencilla, Goodman, Christopher D., Senthi, Sashendra

2024

Overview

Background 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. Methods 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. Discussion 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. Trial registration Clinicaltrials.gov NCT05717166 (registration date: Feb. 8, 2023).

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Ablation (Surgery) / Aged / Analysis / Biological markers / Cancer / Cancer patients / Cancer therapies / Care and treatment / Clinical trials / Clinical Trials, Phase II as Topic / Clinical Trials, Phase III as Topic / Development and progression / Diagnosis / Female / Health aspects / Histology / Humans / Liver / Magnetic resonance imaging / Male / Medical prognosis / Medical research / Medicine / Medicine & Public Health / Medicine, Experimental / Metastasis / Middle Aged / Neoplasm Metastasis / Neoplasms, Multiple Primary - radiotherapy / Oligometastases / Pain Medicine / Palliative Medicine / Patient outcomes / Patients / Prostate cancer / Quality of life / Quality of Life Research / Radiation / Radiation therapy / Radiosurgery / Radiosurgery - methods / Radiotherapy / Randomized Controlled Trials as Topic / Standard of care / Stereotactic ablative radiotherapy / Study Protocol / Synchronous / Tomography / Tumors