Evidence map›Paper›PMID 38973009›Full record

ArticleBMC cancer2024

A randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HepatoCellular Carcinoma (SOCRATES HCC).

Alan Wigg, Jonathan Tibballs, Richard Woodman, Katherine Stuart, Hien Le, Stuart K Roberts, John K Olynyk, Simone I Strasser, Michael Wallace, Jarad Martin and 32 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

42 authors.

Alan WiggSouthern Adelaide Local Health Network, Adelaide, Australia. alan.wigg@sa.gov.au.
Jonathan TibballsSir Charles Gardiner Hospital, Perth, Australia.
Richard WoodmanFlinders University of South Australia, Adelaide, Australia.
Katherine StuartPrincess Alexandra Hospital, Brisbane, Australia.
Hien LeCentral Adelaide Local Health Network, Adelaide, Australia.
Stuart K RobertsThe Alfred Hospital, Melbourne, Australia.
John K OlynykFiona Stanley Hospital, Perth, Australia.
Simone I StrasserRoyal Prince Alfred Hospital, Sydney, Australia.
Michael WallaceSir Charles Gardiner Hospital, Perth, Australia.
Jarad MartinUniversity of Newcastle, Newcastle, England.
Annette HaworthUniversity of Sydney, Sydney, Australia.
Nicholas HardcastlePeter MacCallum Cancer Centre, Melbourne, Australia.
Kee Fong LooSouthern Adelaide Local Health Network, Adelaide, Australia.
Colin TangSir Charles Gardiner Hospital, Perth, Australia.
Yoo Young LeePrincess Alexandra Hospital, Brisbane, Australia.
Julie ChuPeter MacCallum Cancer Centre, Melbourne, Australia.
Richard De Abreu LourencoUniversity of Technology Sydney, Sydney, Australia.
Adam KoukourouSouthern Adelaide Local Health Network, Adelaide, Australia.
Diederick De BooMonash Health, Melbourne, Australia.
Kate McLeanPrincess Alexandra Hospital, Brisbane, Australia.
Jackie BuckTrans-Tasman Radiation Oncology Group, Waratah, Australia.
Rohit SawhneyEastern Health, Melbourne, Australia.
Amanda NicollEastern Health, Melbourne, Australia.
Anouk DevMonash Health, Melbourne, Australia.
Marnie WoodRoyal Brisbane and Women's Hospital, Brisbane, Australia.
Alicia BraundGold Coast University Hospital, Gold Coast, Australia.
Martin WeltmanNepean Hospital, Sydney, Australia.
Richard KhorAustin Health, Melbourne, Australia.
Miriam LevyLiverpool Hospital, Sydney, Australia.
Tim WangWestmead Hospital, Sydney, Australia.
Michael PotterJohn Hunter Hospital, Newcastle, Australia.
James HaridyRoyal Melbourne Hospital, Melbourne, Australia.
Ashok RajRoyal Melbourne Hospital, Melbourne, Australia.
Oliver DuncanFiona Stanley Hospital, Perth, Australia.
Amany ZekrySt George Hospital, Sydney, Australia.
Natalie CollierWollongong Hospital, Wollongong, Australia.
James O'BeirneSunshine Coast University Hospital, Sunshine Coast, Australia.
Catherine HollidayCentre for Community-Driven Research, Sydney, Australia.
Yuvnik TradaCalvary Mater, Newcastle, Australia.
Jaw TronidjajaJohn Hunter Hospital, Newcastle, Australia.
Jacob GeorgeUniversity of Sydney, Sydney, Australia.
David PryorPrincess Alexandra Hospital, Brisbane, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTherapeutic 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.

methodsTrans-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 registrationanzctr.org.au, ACTRN12621001444875, registered 21 October 2021.

Indexed as

Carcinoma, HepatocellularLiver NeoplasmsRadiosurgeryStandard of CareAdultAgedClinical Trials, Phase II as TopicFemaleHumansMaleMiddle AgedNeoplasm StagingProspective StudiesRandomized Controlled Trials as TopicEarly-stage hepatocellular carcinomaSABRSBRTStereotactic ablative radiotherapyThermal ablationTransarterial therapiesTreatment stage migration

Identifiers

PMID38973009
PMCPMC11229272

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.