Evidence map›Paper›PMID 28578652›Full record

Trial reportBMC cancer2017

ICORG 10-14: NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study (Neo-AEGIS).

J V Reynolds, S R Preston, B O'Neill, L Baeksgaard, S M Griffin, C Mariette, S Cuffe, M Cunningham, T Crosby, I Parker and 24 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01726452 (Neo-AEGIS), which is not on this map. Cited by 67 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 1 pooled it
18.6field-weighted citation impact, top 1% 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.

NCT01726452 phase3completednot on this map

Neo-AEGIS (NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study): Randomised Clinical Trial of Neoadjuvant and Adjuvant Chemotherapy (Modified MAGIC or FLOT Regimen) vs. Neoadjuvant Chemoradiation (CROSS Protocol) in Adenocarcinoma of the Oesophagus and Oesophago-gastric Junction

TypeinterventionalSponsorCancer Trials IrelandRan2013 to 2022Enrolled377ConditionsAdenocarcinoma of the Oesophagus, Adenocarcinoma of the Oesophago-gastric Junction, Oesophageal Tumours, Junctional TumoursArmsEpirubicin, Cisplatin / Oxaliplatin, 5 Flourouracil/ Capecitabine, (41.4 Gy/23 fractions), Paclitaxel
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 1 synthesis or guideline pooled it, 156 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Effect of preoperative inspiratory muscle training on physical functioning following esophagectomy.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2019
    Trial
  7. Article
  8. Observational
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Current neoadjuvant therapy for operable locally advanced esophageal cancer.Medical oncology (Northwood, London, England) · 2023
    Review
  19. Review
  20. Review

7 more citing papers are in PubMed but not listed here.

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

34 authors at 12 institutions in 4 countries.

J V ReynoldsSt. James's Hospital and Trinity College Dublin, Dublin, Ireland. reynoljv@tcd.ie.
S R PrestonRoyal Surrey County Hospital, Guildford, UK.
B O'NeillBeaumont Hospital, Dublin, Ireland.
L BaeksgaardRigshospitalet, Copenhagen, Denmark.
S M GriffinRoyal Victoria Infirmary, Newcastle, UK.
C MarietteUniversity Hospital C. Huriez Place de Verdun, Lille, France.
S CuffeSt. James's Hospital and Trinity College Dublin, Dublin, Ireland.
M CunninghamSt. James's Hospital and Trinity College Dublin, Dublin, Ireland.
T CrosbyVelindre Cancer Centre, Cardiff, Wales, UK.
I ParkerSt Mary's Hospital and Imperial College London, London, UK.
K HoflandRigshospitalet, Copenhagen, Denmark.
G HannaSt Mary's Hospital and Imperial College London, London, UK.
L B SvendsenRigshospitalet, Copenhagen, Denmark.
C L DonohoeSt. James's Hospital and Trinity College Dublin, Dublin, Ireland.
C MuldoonSt. James's Hospital and Trinity College Dublin, Dublin, Ireland.
D O'TooleSt. James's Hospital and Trinity College Dublin, Dublin, Ireland.
C JohnsonSt. James's Hospital and Trinity College Dublin, Dublin, Ireland.
N RaviSt. James's Hospital and Trinity College Dublin, Dublin, Ireland.
G JonesVelindre Cancer Centre, Cardiff, Wales, UK.
A K CorkhillSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
M IllsleyRoyal Surrey County Hospital, Guildford, UK.
J MellorSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
K LeeSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
M DibUniversity Hospital C. Huriez Place de Verdun, Lille, France.
V MarchesinIrish Clinical Oncology Research Group (ICORG), Dublin, Ireland.
M CunnaneIrish Clinical Oncology Research Group (ICORG), Dublin, Ireland.
K ScottIrish Clinical Oncology Research Group (ICORG), Dublin, Ireland.
P LawnerIrish Clinical Oncology Research Group (ICORG), Dublin, Ireland.
S WarrenSt. James's Hospital and Trinity College Dublin, Dublin, Ireland.
S O'ReillyIrish Clinical Oncology Research Group (ICORG), Dublin, Ireland.
G O'DowdIrish Clinical Oncology Research Group (ICORG), Dublin, Ireland.
G LeonardIrish Clinical Oncology Research Group (ICORG), Dublin, Ireland.
B HennessyIrish Clinical Oncology Research Group (ICORG), Dublin, Ireland.
R Mc DermottIrish Clinical Oncology Research Group (ICORG), Dublin, Ireland.
Cancer Trials Ireland · IETrinity College Dublin · IESt. James's Hospital · IERigshospitalet · DKUniversity of Southampton · GBHôpital Claude Huriez · FRRoyal Surrey County Hospital · GBVelindre Cancer Centre · GBBeaumont Hospital · IEImperial College London · GBRoyal Victoria Infirmary · GBSt Mary's Hospital · GB

Funding

Cancer Research UK 15956Cancer Research UK 18483
6 · The paper itself

Abstract

backgroundNeoadjuvant therapy is increasingly the standard of care in the management of locally advanced adenocarcinoma of the oesophagus and junction (AEG). In randomised controlled trials (RCTs), the MAGIC regimen of pre- and postoperative chemotherapy, and the CROSS regimen of preoperative chemotherapy combined with radiation, were superior to surgery only in RCTs that included AEG but were not powered on this cohort. No completed RCT has directly compared neoadjuvant or perioperative chemotherapy and neoadjuvant chemoradiation. The Neo-AEGIS trial, uniquely powered on AEG, and including comprehensive modern staging, compares both these regimens.

methodsThis open label, multicentre, phase III RCT randomises patients (cT2-3, N0-3, M0) in a 1:1 fashion to receive CROSS protocol (Carboplatin and Paclitaxel with concurrent radiotherapy, 41.4Gy/23Fr, over 5 weeks). The power calculation is a 10% difference in favour of CROSS, powered at 80%, two-sided alpha level of 0.05, requiring 540 patients to be evaluable, 594 to be recruited if a 10% dropout is included (297 in each group). The primary endpoint is overall survival, with a minimum 3-year follow up. Secondary endpoints include: disease free survival, recurrence rates, clinical and pathological response rates, toxicities of induction regimens, post-operative pathology and tumour regression grade, operative in-hospital complications, and health-related quality of life. The trial also affords opportunities for establishing a bio-resource of pre-treatment and resected tumour, and translational research. DISCUSSION: This RCT directly compares two established treatment regimens, and addresses whether radiation therapy positively impacts on overall survival compared with a standard perioperative chemotherapy regimen Sponsor: Irish Clinical Research Group (ICORG).

trial registrationNCT01726452 . Protocol 10-14. Date of registration 06/11/2012.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinDisease-Free SurvivalEsophageal NeoplasmsEsophagogastric JunctionFemaleHumansMaleMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalPaclitaxelQuality of LifeCarboplatinPaclitaxelAdenocarcinomaNeoadjuvant chemoradiation therapyNeoadjuvant chemotherapyOesophagealOesophagogastric junction

Identifiers

PMID28578652
PMCPMC5457631
OpenAlexW2621287299

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.