Evidence map›Paper›PMID 31268180›Full record

Trial reportThe British journal of surgery2019

Quality assurance of surgery in the randomized ST03 trial of perioperative chemotherapy in carcinoma of the stomach and gastro-oesophageal junction.

W H Allum, E C Smyth, J M Blazeby, H I Grabsch, S M Griffin, S Rowley, F H Cafferty, R E Langley, D Cunningham

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00450203 (A Randomised Phase II/III Trial of Peri-Operative Chemotherapy With or Without Bevacizumab in Operable Oesophagogastric Adenocarcinoma and A Feasibility Study Evaluating Lapatinib in HER-2 Positive Oesophagogastric Adenocarcinomas and), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 24% 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.

NCT00450203 phase2 / phase3unknown statusnot on this map

A Randomised Phase II/III Trial of Peri-Operative Chemotherapy With or Without Bevacizumab in Operable Oesophagogastric Adenocarcinoma and A Feasibility Study Evaluating Lapatinib in HER-2 Positive Oesophagogastric Adenocarcinomas and (in Selected Centres) MRI and PET/CT Sub-studies

TypeinterventionalSponsorProfessor David CunninghamRan2007 to 2017Enrolled1,103ConditionsOesophagogastric CancerArmsbevacizumab, capecitabine, cisplatin, Epirubicin, adjuvant therapy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. 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

9 authors at 5 institutions in 2 countries.

W H AllumGastrointestinal Unit, Royal Marsden NHS Foundation Trust, London, UK.
E C SmythGastrointestinal Unit, Royal Marsden NHS Foundation Trust, London, UK.ORCID 0000-0002-4667-1817
J M BlazebyBristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-3354-3330
H I GrabschPathology and Data Analytics, Leeds Institute of Medical Research at St James's, School of Medicine, University of Leeds, Leeds, UK.
S M GriffinDepartment of Gastrointestinal Surgery, Royal Victoria Infirmary, Newcastle upon Tyne, UK.
S RowleyMedical Research Council Clinical Trials Unit at University College London, London, UK.
F H CaffertyMedical Research Council Clinical Trials Unit at University College London, London, UK.ORCID 0000-0002-0973-660X
R E LangleyMedical Research Council Clinical Trials Unit at University College London, London, UK.
D CunninghamGastrointestinal Unit, Royal Marsden NHS Foundation Trust, London, UK.
Royal Marsden NHS Foundation Trust · GBUniversity College London · GBRoyal Victoria Infirmary · GBUniversity of Bristol · GBUniversity of Leeds · GB

Funding

Cancer Research UK 15499Cancer Research UK 6410Cancer Research UK C1504/A6410Medical Research Council MC_UU_12023/20Medical Research Council MC_UU_12023/28Medical Research Council MR/K025643/1
6 · The paper itself

Abstract

backgroundThe UK Medical Research Council ST03 trial compared perioperative epirubicin, cisplatin and capecitabine (ECX) chemotherapy with or without bevacizumab (B) in gastric and oesophagogastric junctional cancer. No difference in survival was noted between the arms of the trial. The present study reviewed the standards and performance of surgery in the context of the protocol-specified surgical criteria.

methodsSurgical and pathological clinical report forms were reviewed to determine adherence to the surgical protocols, perioperative morbidity and mortality, and final histopathological stage for all patients treated in the study.

resultsOf 1063 patients randomized, 895 (84·2 per cent) underwent resection; surgical details were available for 880 (98·3 per cent). Postoperative assessment data were available for 873 patients; complications occurred in 458 (52·5 per cent) overall, of whom 71 (8·1 per cent) developed complications deemed to be life-threatening by the responsible clinician. The most common complications were respiratory (211 patients, 24·2 per cent). The anastomotic leak rate was 118 of 873 (13·5 per cent) overall; among those who underwent oesophagogastrectomy, the rate was higher in the group receiving ECX-B (23·6 per cent versus 9·9 per cent in the ECX group). Pathological assessment data were available for 845 patients. At least 15 nodes were removed in 82·5 per cent of resections and the median lymph node harvest was 24 (i.q.r. 17-34). Twenty-five or more nodes were removed in 49·0 per cent of patients. Histopathologically, the R1 rate was 24·9 per cent (208 of 834 patients). An R1 resection was more common for proximal tumours.

conclusionIn the ST03 trial, the performance of surgery met the protocol-stipulated criteria. Registration number: NCT00450203 ( http://www.clinicaltrials.gov).

Indexed as

AdenocarcinomaEsophagogastric JunctionQuality Assurance, Health CareStomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCapecitabineCisplatinCombined Modality TherapyEpirubicinGastrectomyHumansStomachBevacizumabCapecitabineCisplatinEpirubicin

Identifiers

PMID31268180
PMCPMC6771829
OpenAlexW2946134515

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.