PMID- 38310262
OWN - NLM
STAT- MEDLINE
DCOM- 20240208
LR  - 20240326
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 24
IP  - 1
DP  - 2024 Feb 3
TI  - Single vs. multiple fraction non-inferiority trial of stereotactic ablative 
      radiotherapy for the comprehensive treatment of oligo-metastases/progression: 
      SIMPLIFY-SABR-COMET.
PG  - 171
LID - 10.1186/s12885-024-11905-7 [doi]
LID - 171
AB  - 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.
CI  - (c) 2024. The Author(s).
FAU - Olson, Robert
AU  - Olson R
AD  - University of British Columbia, Vancouver, Canada. rolson2@bccancer.bc.ca.
AD  - University of Northern British Columbia, Prince George, Canada. 
      rolson2@bccancer.bc.ca.
AD  - BC Cancer - Prince George, 1215 Lethbridge Street, Prince George, BC, V2M7A9, 
      Canada. rolson2@bccancer.bc.ca.
AD  - Department of Radiation Oncology, BC Cancer - Centre for the North, 1215 
      Lethbridge Street, Prince George, British Columbia, V2M 7E9, Canada. 
      rolson2@bccancer.bc.ca.
FAU - Abraham, Hadassah
AU  - Abraham H
AD  - BC Cancer - Prince George, 1215 Lethbridge Street, Prince George, BC, V2M7A9, 
      Canada.
FAU - Leclerc, Curtis
AU  - Leclerc C
AD  - University of British Columbia, Vancouver, Canada.
AD  - BC Cancer - Prince George, 1215 Lethbridge Street, Prince George, BC, V2M7A9, 
      Canada.
FAU - Benny, Alexander
AU  - Benny A
AD  - University of British Columbia, Vancouver, Canada.
FAU - Baker, Sarah
AU  - Baker S
AD  - BC Cancer - Surrey, Surrey, British Columbia, Canada.
FAU - Matthews, Quinn
AU  - Matthews Q
AD  - BC Cancer - Prince George, 1215 Lethbridge Street, Prince George, BC, V2M7A9, 
      Canada.
FAU - Chng, Nick
AU  - Chng N
AD  - BC Cancer - Prince George, 1215 Lethbridge Street, Prince George, BC, V2M7A9, 
      Canada.
FAU - Bergman, Alanah
AU  - Bergman A
AD  - BC Cancer - Vancouver, Vancouver, British Columbia, Canada.
FAU - Mou, Benjamin
AU  - Mou B
AD  - BC Cancer - Kelowna, Kelowna, British Columbia, Canada.
FAU - Dunne, Emma M
AU  - Dunne EM
AD  - BC Cancer - Vancouver, Vancouver, British Columbia, Canada.
FAU - Schellenberg, Devin
AU  - Schellenberg D
AD  - BC Cancer - Surrey, Surrey, British Columbia, Canada.
FAU - Jiang, Will
AU  - Jiang W
AD  - BC Cancer - Surrey, Surrey, British Columbia, Canada.
FAU - Chan, Elisa
AU  - Chan E
AD  - BC Cancer - Vancouver, Vancouver, British Columbia, Canada.
FAU - Atrchian, Siavash
AU  - Atrchian S
AD  - BC Cancer - Kelowna, Kelowna, British Columbia, Canada.
FAU - Lefresne, Shilo
AU  - Lefresne S
AD  - BC Cancer - Vancouver, Vancouver, British Columbia, Canada.
FAU - Carolan, Hannah
AU  - Carolan H
AD  - BC Cancer - Vancouver, Vancouver, British Columbia, Canada.
FAU - Valev, Boris
AU  - Valev B
AD  - BC Cancer- Victoria, Victoria, British Columbia, Canada.
FAU - Tyldesley, Scott
AU  - Tyldesley S
AD  - BC Cancer - Vancouver, Vancouver, British Columbia, Canada.
FAU - Bang, Andrew
AU  - Bang A
AD  - BC Cancer - Vancouver, Vancouver, British Columbia, Canada.
FAU - Berrang, Tanya
AU  - Berrang T
AD  - BC Cancer- Victoria, Victoria, British Columbia, Canada.
FAU - Clark, Haley
AU  - Clark H
AD  - BC Cancer - Surrey, Surrey, British Columbia, Canada.
FAU - Hsu, Fred
AU  - Hsu F
AD  - BC Cancer- Abbotsford, Abbotsford, British Columbia, Canada.
FAU - Louie, Alexander V
AU  - Louie AV
AD  - Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health 
      Sciences Centre, Toronto, Ontario, Canada.
FAU - Warner, Andrew
AU  - Warner A
AD  - Department of Oncology, London Health Sciences Centre, London, Ontario, Canada.
FAU - Palma, David A
AU  - Palma DA
AD  - Department of Oncology, London Health Sciences Centre, London, Ontario, Canada.
FAU - Howell, Doris
AU  - Howell D
AD  - Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
FAU - Barry, Aisling
AU  - Barry A
AD  - Cork University Hospital, Cork, Ireland.
FAU - Dawson, Laura
AU  - Dawson L
AD  - Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
FAU - Grendarova, Petra
AU  - Grendarova P
AD  - BC Cancer- Victoria, Victoria, British Columbia, Canada.
FAU - Walker, Debra
AU  - Walker D
AD  - Patient partner, BC Cancer-Prince George, Prince George, BC, Canada.
FAU - Sinha, Rishi
AU  - Sinha R
AD  - Tom Baker Cancer Centre, Calgary, Alberta, Canada.
FAU - Tsai, Jillian
AU  - Tsai J
AD  - Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
FAU - Bahig, Houda
AU  - Bahig H
AD  - Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal, Quebec, Canada.
FAU - Thibault, Isabelle
AU  - Thibault I
AD  - Centre Hospitalier Universitaire de Quebec (CHUQ), Quebec, Canada.
FAU - Koul, Rashmi
AU  - Koul R
AD  - Cancer Care Manitoba, Winnipeg, Manitoba, Canada.
FAU - Senthi, Sashendra
AU  - Senthi S
AD  - Alfred Health Radiation Oncology, Melbourne, Australia.
FAU - Phillips, Iain
AU  - Phillips I
AD  - Western General Hospital/Edinburgh Cancer Centre, Edinburgh, Scotland.
FAU - Grose, Derek
AU  - Grose D
AD  - Beatson West of Scotland Cancer Centre, Glasgow, Scotland.
FAU - Kelly, Paul
AU  - Kelly P
AD  - Bon Secours Radiotherapy Cork (In Partnership with UPMC Hillman Cancer Centre), 
      Cork, Ireland.
FAU - Armstrong, John
AU  - Armstrong J
AD  - St. Luke's Radiation Oncology Network, Dublin, Ireland.
FAU - McDermott, Ronan
AU  - McDermott R
AD  - University Hospital Galway, Galway, Ireland.
FAU - Johnstone, Candice
AU  - Johnstone C
AD  - Medical College of Wisconsin, Milwaukee, Wisconsin, United States of America.
FAU - Vasan, Srini
AU  - Vasan S
AD  - Precision Cancer Center, Ashland, Kentucky, United States of America.
FAU - Aherne, Noel
AU  - Aherne N
AD  - Riverina Cancer Care Centre, Wagga Wagga, New South Wales, Australia.
FAU - Harrow, Stephen
AU  - Harrow S
AD  - Western General Hospital/Edinburgh Cancer Centre, Edinburgh, Scotland.
FAU - Liu, Mitchell
AU  - Liu M
AD  - BC Cancer - Vancouver, Vancouver, British Columbia, Canada.
LA  - eng
SI  - ClinicalTrials.gov/NCT05784428
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20240203
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
SB  - IM
MH  - Humans
MH  - *Neoplasms/mortality/pathology/radiotherapy
MH  - Progression-Free Survival
MH  - Quality of Life
MH  - *Radiosurgery/adverse effects/methods
MH  - Equivalence Trials as Topic
PMC - PMC10838428
OTO - NOTNLM
OT  - Cancer
OT  - Oligometastases
OT  - Quality of Life
OT  - Single Fraction
OT  - Stereotactic ablative radiotherapy
OT  - Survival
COIS- 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.
EDAT- 2024/02/04 00:42
MHDA- 2024/02/05 06:43
PMCR- 2024/02/03
CRDT- 2024/02/03 23:25
PHST- 2023/12/18 00:00 [received]
PHST- 2024/01/21 00:00 [accepted]
PHST- 2024/02/05 06:43 [medline]
PHST- 2024/02/04 00:42 [pubmed]
PHST- 2024/02/03 23:25 [entrez]
PHST- 2024/02/03 00:00 [pmc-release]
AID - 10.1186/s12885-024-11905-7 [pii]
AID - 11905 [pii]
AID - 10.1186/s12885-024-11905-7 [doi]
PST - epublish
SO  - BMC Cancer. 2024 Feb 3;24(1):171. doi: 10.1186/s12885-024-11905-7.