Evidence map›Paper›PMID 36310299›Full record

Trial reportJournal of cancer research and clinical oncology2023

Value of central review of RECIST v1.1 outcomes in the AGITG INTEGRATE randomised phase 2 international trial for advanced oesophago-gastric cancer.

Katrin M Sjoquist, Andrew Martin, Nick Pavlakis, David Goldstein, Eric Tsobanis, Daniel Moses, Richard Maher, Wendy Hague, Val Gebski, Martin R Stockler and 2 more

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 76% of its field
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

1 citing paper in PubMed, 0 citations in OpenAlex.

  1. Article
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

12 authors at 4 institutions in 1 country.

Katrin M SjoquistNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia. Katrin.sjoquist@sydney.edu.au.ORCID http://orcid.org/0000-0001-9028-8682
Andrew MartinNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Nick PavlakisDepartment of Medical Oncology, Royal North Shore Hospital, Sydney, Australia.
David GoldsteinPrince of Wales Hospital, Sydney, Australia.
Eric TsobanisNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Daniel MosesPrince of Wales Hospital, Sydney, Australia.
Richard MaherRadiology Department, Royal North Shore Hospital, Sydney, Australia.
Wendy HagueNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Val GebskiNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Martin R StocklerNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
R John SimesNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Australasian Gastro-Intestinal Trials Group (AGITG)
The University of Sydney · AURoyal North Shore Hospital · AUPrince of Wales Hospital · AUUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeActivity estimates should be accurately evaluated in phase 2 clinical trials to ensure appropriate decisions about proceeding to phase 3 trials. RECIST v1.1. progression-free survival (PFS) is a common endpoint in oncology; however, it can be influenced by assessment criteria and trial design. We assessed the value of central adjudication of investigator-assessed PFS times of participants in a double-blind, randomised phase 2 trial evaluating regorafenib versus placebo in advanced gastro-oesophageal cancer (AGITG INTEGRATE) to inform plans for central review in future trials.

methodsWe calculated the proportion of participants with a disagreement between the site investigator assessment and blinded independent central review and in whom central review resulted in a change, then evaluated the effect of central review on study conclusions by comparing hazard ratios (HRs) for PFS based on site review versus central review. Post-progression unblinding was assessed with similar methods. Simulation studies explored the effect of differential and non-differential measurement error on treatment effect estimation and study power.

resultsDisagreements between site assessments versus central review occurred in 8/147 (5.4%) participants, 5 resulting in amended date of progression (3.4%). PFS HRs (sites vs central review progression dates) were similar (0.39 vs 0.40). RECIST progression occurred in 82/86 (95%) of cases where post-progression unblinding was requested by the site investigator.

conclusionsBlinded independent central review was feasible and supported the reliability of site assessments, trial results, and conclusions. Modelling showed that when treatment effects were large and outcome assessments blinded, central review was unlikely to affect conclusions.

Indexed as

Esophageal NeoplasmsStomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodHumansProgression-Free SurvivalReproducibility of ResultsResponse Evaluation Criteria in Solid TumorsClinical trialOesophageal cancerProgression-free survivalResponse evaluation criteria in solid tumoursTreatment effectiveness

Identifiers

PMID36310299
PMCPMC10349725
OpenAlexW4307771979

What OpenQuestion holds

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LicenceCC BY
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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.