TY - JOUR
T1 - A randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HepatoCellular Carcinoma (SOCRATES HCC)
AU - Wigg, Alan
AU - Tibballs, Jonathan
AU - Woodman, Richard
AU - Stuart, Katherine
AU - Le, Hien
AU - Roberts, Stuart K.
AU - Olynyk, John K.
AU - Strasser, Simone I.
AU - Wallace, Michael
AU - Martin, Jarad
AU - Haworth, Annette
AU - Hardcastle, Nicholas
AU - Loo, Kee Fong
AU - Tang, Colin
AU - Lee, Yoo Young
AU - Chu, Julie
AU - De Abreu Lourenco, Richard
AU - Koukourou, Adam
AU - De Boo, Diederick
AU - McLean, Kate
AU - Buck, Jackie
AU - Sawhney, Rohit
AU - Nicoll, Amanda
AU - Dev, Anouk
AU - Wood, Marnie
AU - Braund, Alicia
AU - Weltman, Martin
AU - Khor, Richard
AU - Levy, Miriam
AU - Wang, Tim
AU - Potter, Michael
AU - Haridy, James
AU - Raj, Ashok
AU - Duncan, Oliver
AU - Zekry, Amany
AU - Collier, Natalie
AU - O’Beirne, James
AU - Holliday, Catherine
AU - Trada, Yuvnik
AU - Tronidjaja, Jaw
AU - George, Jacob
AU - Pryor, David
PY - 2024/7/8
Y1 - 2024/7/8
N2 - Background: Therapeutic options for early-stage hepatocellular carcinoma (HCC) in individual patients can be limited by tumor and location, liver dysfunction and comorbidities. Many patients with early-stage HCC do not receive curative-intent therapies. Stereotactic ablative body radiotherapy (SABR) has emerged as an effective, non-invasive HCC treatment option, however, randomized evidence for SABR in the first line setting is lacking. Methods: Trans-Tasman Radiation Oncology Group (TROG) 21.07 SOCRATES-HCC is a phase II, prospective, randomised trial comparing SABR to other current standard of care therapies for patients with a solitary HCC ≤ 8 cm, ineligible for surgical resection or transplantation. The study is divided into 2 cohorts. Cohort 1 will compromise 118 patients with tumors ≤ 3 cm eligible for thermal ablation randomly assigned (1:1 ratio) to thermal ablation or SABR. Cohort 2 will comprise 100 patients with tumors > 3 cm up to 8 cm in size, or tumors ≤ 3 cm ineligible for thermal ablation, randomly assigned (1:1 ratio) to SABR or best other standard of care therapy including transarterial therapies. The primary objective is to determine whether SABR results in superior freedom from local progression (FFLP) at 2 years compared to thermal ablation in cohort 1 and compared to best standard of care therapy in cohort 2. Secondary endpoints include progression free survival, overall survival, adverse events, patient reported outcomes and health economic analyses. Discussion: The SOCRATES-HCC study will provide the first randomized, multicentre evaluation of the efficacy, safety and cost effectiveness of SABR versus other standard of care therapies in the first line treatment of unresectable, early-stage HCC. It is a broad, multicentre collaboration between hepatology, interventional radiology and radiation oncology groups around Australia, coordinated by TROG Cancer Research. Trial registration: anzctr.org.au, ACTRN12621001444875, registered 21 October 2021.
AB - Background: Therapeutic options for early-stage hepatocellular carcinoma (HCC) in individual patients can be limited by tumor and location, liver dysfunction and comorbidities. Many patients with early-stage HCC do not receive curative-intent therapies. Stereotactic ablative body radiotherapy (SABR) has emerged as an effective, non-invasive HCC treatment option, however, randomized evidence for SABR in the first line setting is lacking. Methods: Trans-Tasman Radiation Oncology Group (TROG) 21.07 SOCRATES-HCC is a phase II, prospective, randomised trial comparing SABR to other current standard of care therapies for patients with a solitary HCC ≤ 8 cm, ineligible for surgical resection or transplantation. The study is divided into 2 cohorts. Cohort 1 will compromise 118 patients with tumors ≤ 3 cm eligible for thermal ablation randomly assigned (1:1 ratio) to thermal ablation or SABR. Cohort 2 will comprise 100 patients with tumors > 3 cm up to 8 cm in size, or tumors ≤ 3 cm ineligible for thermal ablation, randomly assigned (1:1 ratio) to SABR or best other standard of care therapy including transarterial therapies. The primary objective is to determine whether SABR results in superior freedom from local progression (FFLP) at 2 years compared to thermal ablation in cohort 1 and compared to best standard of care therapy in cohort 2. Secondary endpoints include progression free survival, overall survival, adverse events, patient reported outcomes and health economic analyses. Discussion: The SOCRATES-HCC study will provide the first randomized, multicentre evaluation of the efficacy, safety and cost effectiveness of SABR versus other standard of care therapies in the first line treatment of unresectable, early-stage HCC. It is a broad, multicentre collaboration between hepatology, interventional radiology and radiation oncology groups around Australia, coordinated by TROG Cancer Research. Trial registration: anzctr.org.au, ACTRN12621001444875, registered 21 October 2021.
KW - Early-stage hepatocellular carcinoma
KW - SABR
KW - SBRT
KW - Stereotactic ablative radiotherapy
KW - Thermal ablation
KW - Transarterial therapies
KW - Treatment stage migration
UR - http://www.scopus.com/inward/record.url?scp=85197723873&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/NHMRC/2014627
U2 - 10.1186/s12885-024-12504-2
DO - 10.1186/s12885-024-12504-2
M3 - Article
C2 - 38973009
AN - SCOPUS:85197723873
SN - 1471-2407
VL - 24
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 813
ER -
