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. 2024 Feb 3;24(1):171.
doi: 10.1186/s12885-024-11905-7.

Single vs. multiple fraction non-inferiority trial of stereotactic ablative radiotherapy for the comprehensive treatment of oligo-metastases/progression: SIMPLIFY-SABR-COMET

Robert Olson  1   2   3   4 , Hadassah Abraham  5 , Curtis Leclerc  6   5 , Alexander Benny  6 , Sarah Baker  7 , Quinn Matthews  5 , Nick Chng  5 , Alanah Bergman  8 , Benjamin Mou  9 , Emma M Dunne  8 , Devin Schellenberg  7 , Will Jiang  7 , Elisa Chan  8 , Siavash Atrchian  9 , Shilo Lefresne  8 , Hannah Carolan  8 , Boris Valev  10 , Scott Tyldesley  8 , Andrew Bang  8 , Tanya Berrang  10 , Haley Clark  7 , Fred Hsu  11 , Alexander V Louie  12 , Andrew Warner  13 , David A Palma  13 , Doris Howell  14 , Aisling Barry  15 , Laura Dawson  14 , Petra Grendarova  10 , Debra Walker  16 , Rishi Sinha  17 , Jillian Tsai  14 , Houda Bahig  18 , Isabelle Thibault  19 , Rashmi Koul  20 , Sashendra Senthi  21 , Iain Phillips  22 , Derek Grose  23 , Paul Kelly  24 , John Armstrong  25 , Ronan McDermott  26 , Candice Johnstone  27 , Srini Vasan  28 , Noel Aherne  29 , Stephen Harrow  22 , Mitchell Liu  8
Affiliations

Single vs. multiple fraction non-inferiority trial of stereotactic ablative radiotherapy for the comprehensive treatment of oligo-metastases/progression: SIMPLIFY-SABR-COMET

Robert Olson et al. BMC Cancer. .

Abstract

Background: Radiotherapy delivery regimens can vary between a single fraction (SF) and multiple fractions (MF) given daily for up to several weeks depending on the location of the cancer or metastases. With limited evidence comparing fractionation regimens for oligometastases, there is support to explore toxicity levels to nearby organs at risk as a primary outcome while using SF and MF stereotactic ablative radiotherapy (SABR) as well as explore differences in patient-reported quality of life and experience.

Methods: This study will randomize 598 patients in a 1:1 ratio between the standard arm (MF SABR) and the experimental arm (SF SABR). This trial is designed as two randomized controlled trials within one patient population for resource efficiency. The primary objective of the first randomization is to determine if SF SABR is non-inferior to MF SABR, with respect to healthcare provider (HCP)-reported grade 3-5 adverse events (AEs) that are related to SABR. Primary endpoint is toxicity while secondary endpoints include lesional control rate (LCR), and progression-free survival (PFS). The second randomization (BC Cancer sites only) will allocate participants to either complete quality of life (QoL) questionnaires only; or QoL questionnaires and a symptom-specific survey with symptom-guided HCP intervention. The primary objective of the second randomization is to determine if radiation-related symptom questionnaire-guided HCP intervention results in improved reported QoL as measured by the EuroQoL-5-dimensions-5levels (EQ-5D-5L) instrument. The primary endpoint is patient-reported QoL and secondary endpoints include: persistence/resolution of symptom reporting, QoL, intervention cost effectiveness, resource utilization, and overall survival.

Discussion: This study will compare SF and MF SABR in the treatment of oligometastases and oligoprogression to determine if there is non-inferior toxicity for SF SABR in selected participants with 1-5 oligometastatic lesions. This study will also compare patient-reported QoL between participants who receive radiation-related symptom-guided HCP intervention and those who complete questionnaires alone.

Trial registration: Clinicaltrials.gov identifier: NCT05784428. Date of Registration: 23 March 2023.

Keywords: Cancer; Oligometastases; Quality of Life; Single Fraction; Stereotactic ablative radiotherapy; Survival.

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Conflict of interest statement

RO has received grant funding from Varian Medical Systems, related to the current study, as well as speaker fees from Astra Zeneca and works in a consultant role with equity from Need Inc, both unrelated to the current work.

SB has received speaker’s honoraria from Astra Zeneca.

BM has received honoraria from Astra Zeneca, Bristol Meyers Squibb, and Amgen.

AL has received honoraria from Astra Zeneca for speaker’s bureau and advisory board participation.

DP reports a Clinician-Scientist Grant from the Ontario Institute for Cancer Research, royalties from Uptodate.com, and a consultant role with equity from Need Inc, all unrelated to the current work.

All other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study schema
See this image and copyright information in PMC

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