학술논문
Single vs. multiple fraction non-inferiority trial of stereotactic ablative radiotherapy for the comprehensive treatment of oligo-metastases/progression: SIMPLIFY-SABR-COMET
Document Type
article
Author
Robert Olson; Hadassah Abraham; Curtis Leclerc; Alexander Benny; Sarah Baker; Quinn Matthews; Nick Chng; Alanah Bergman; Benjamin Mou; Emma M. Dunne; Devin Schellenberg; Will Jiang; Elisa Chan; Siavash Atrchian; Shilo Lefresne; Hannah Carolan; Boris Valev; Scott Tyldesley; Andrew Bang; Tanya Berrang; Haley Clark; Fred Hsu; Alexander V. Louie; Andrew Warner; David A. Palma; Doris Howell; Aisling Barry; Laura Dawson; Petra Grendarova; Debra Walker; Rishi Sinha; Jillian Tsai; Houda Bahig; Isabelle Thibault; Rashmi Koul; Sashendra Senthi; Iain Phillips; Derek Grose; Paul Kelly; John Armstrong; Ronan McDermott; Candice Johnstone; Srini Vasan; Noel Aherne; Stephen Harrow; Mitchell Liu
Source
BMC Cancer, Vol 24, Iss 1, Pp 1-14 (2024)
Subject
Language
English
ISSN
1471-2407
Abstract
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.