SARON: stereotactic ablative radiotherapy for oligometastatic non-small cell lung cancer (NSCLC)
Mak, K. M. McDonald, F. Teague, J. Faivre-Finn, C. Forster, M. Hanna, G. Moinuddin, S. Conibear, J. Harden, S. Popat, S.
Mak, K. M.
McDonald, F.
Teague, J.
Faivre-Finn, C.
Forster, M.
Hanna, G.
Moinuddin, S.
Conibear, J.
Harden, S.
Popat, S.
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Abstract
Oligometastatic NSCLC patients have better outcomes than those
with the higher disease burden associated with wider spread
metastatic disease. SABR/SRS have been extensively reported to
result in excellent local control of individual metastatic deposits
with low rates of grade 3+ toxicity. SARON is a randomised controlled phase-III trial to investigate the impact of conventional
RT and SABR/SRS in oligometastatic NSCLC patients suitable for
radical treatment (maximum of 5 metastases involving a maximum of 3 organs, in-line with the recent EORTC consensus definition of
synchronous oligometastatic disease). SARON is a multi-centre,
randomised-controlled trial (RCT) with an original target sample
size of 340. Patients are randomised in 1:1 ratio to standard of
care (SOC) alone or SOC plus radiotherapy to all disease sites.
SOC in the UK in this patient population is systemic anti-cancer
therapy (SACT): mono-chemotherapy, mono-immunotherapy
or combination of chemo-immunotherapy, chosen according to
standard guidelines. SARON opened for recruitment in 08/2016; 20
centres are open to date (06/12/2021) with 136 patients registered,
89 randomised. Following initial recruitment difficulties due to the
changing landscape of SOC treatment and the subsequent impact
of the pandemic, we are in the process of implementing a protocol
amendment to change the design from a phase-III RCT to a practice informing phase-II RCT. The subsequent reduction in required
sample size to 134 randomised patients, whilst keeping a primary
endpoint of overall survival, will ensure that the study objectives
remain scientifically relevant at the expected time of reporting in
early 2026. In addition to the significance level and power being
relaxed, original assumptions regarding estimates for median
overall survival in the control arm following the change to SACT and
length of recruitment period have been re-estimated. In moving to
a phase-II design, SARON will remain an important clinical trial that
will help guiding management of this complex patient population.
Affiliation
Description
Date
2022
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Mak KM, McDonald F, Teague J, Faivre-Finn C, Forster M, Hanna G, et al. SARON: stereotactic ablative radiotherapy for oligometastatic non-small cell lung cancer (NSCLC). Vol. 165, Lung Cancer. Elsevier BV; 2022. p. S71.