Evidence map›Paper›PMID 30200910›Full record

Trial reportBMC cancer2018

CRITICS-II: a multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery versus neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer.

Astrid E Slagter, Edwin P M Jansen, Hanneke W M van Laarhoven, Johanna W van Sandick, Nicole C T van Grieken, Karolina Sikorska, Annemieke Cats, Pietje Muller-Timmermans, Maarten C C M Hulshof, Henk Boot and 12 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 74 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 3 pooled it
–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.

NCT02931890 phase2active not recruitingnot on this map

A Multicentre Randomised Phase II Trial of Neo-adjuvant Chemotherapy Followed by Surgery vs. Neo-adjuvant Chemotherapy and Subsequent Chemoradiotherapy Followed by Surgery vs. Neo-adjuvant Chemoradiotherapy Followed by Surgery in Resectable Gastric Cancer

TypeinterventionalSponsorThe Netherlands Cancer InstituteRan2017 to 2029Enrolled207ConditionsGastric CancerArmsDocetaxel, Oxaliplatin, Capecitabine, gastrectomy, radiotherapy of gastric cancer
NCT05161572 phase2terminatednot on this mapstarted 2021, after this paper: background citation

A Randomized Phase II Trial of Perioperative Chemoimmunotherapy Verses Perioperative Chemoimmunotherapy Plus Preoperative Chemoradiation for Locally Advanced Gastric (G) or Gastroesophageal Junction (GEJ) Adenocarcinoma

TypeinterventionalSponsorFudan UniversityRan2021 to 2022Enrolled6ConditionsStomach Neoplasms, Esophagogastric Junction Disorder, Neoadjuvant Therapy, ChemoradiotherapyArmsOxaliplatin, Tegafur-Gimeracil-Oteracil, Sintilimab, Concurrent chemoradiation, D2/R0 gastrectomy
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  2. Evolution of treatment in gastric cancer- a systematic review.Journal of the Egyptian National Cancer Institute · 2022
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  11. Perioperative immunotherapy in gastric cancer in the spotlight.World journal of clinical oncology · 2025
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14 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

22 authors.

Astrid E SlagterDepartment of Radiation Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Edwin P M JansenDepartment of Radiation Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Hanneke W M van LaarhovenDepartment of Medical Oncology, Academic Medical Center Amsterdam, Meibergdreef 9, 1106 AZ, Amsterdam, The Netherlands.
Johanna W van SandickDepartment of Surgery, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Nicole C T van GriekenDepartment of Pathology, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Karolina SikorskaStatistical Department, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Annemieke CatsDepartment of Gastroenterology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Pietje Muller-TimmermansDepartment of Radiation Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Maarten C C M HulshofDepartment of Radiation Oncology, Academic Medical Center Amsterdam, Meibergdreef 9, 1106 AZ, Amsterdam, The Netherlands.
Henk BootDepartment of Gastroenterology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Maartje LosDepartment of Medical Oncology, St. Antonius Hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands.
Laurens V BeerepootDepartment of Medical Oncology, St. Elisabeth Hospital, Hilvarenbeekse Weg 60, 5022 GC, Tilburg, The Netherlands.
Frank P J PetersDepartment of Medical Oncology, Zuyderland Sittard-Geleen, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.
Geke A P HospersDepartment of Medical Oncology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.
Boudewijn van EttenDepartment of Surgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.
Henk H HartgrinkDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
Mark I van Berge HenegouwenDepartment of Surgery, Academic Medical Center Amsterdam, Meibergdreef 9, 1106 AZ, Amsterdam, The Netherlands.
Grard A P NieuwenhuijzenDepartment of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.
Richard van HillegersbergDepartment of Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3484 CX, Utrecht, The Netherlands.
Donald L van der PeetDepartment of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Heike I GrabschDepartment of Pathology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, P Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
Marcel VerheijDepartment of Radiation Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. m.verheij@nki.nl.

Funding

KWF Kankerbestrijding 10327/2016-1
6 · The paper itself

Abstract

backgroundAlthough radical surgery remains the cornerstone of cure in resectable gastric cancer, survival remains poor. Current evidence-based (neo)adjuvant strategies have shown to improve outcome, including perioperative chemotherapy, postoperative chemoradiotherapy and postoperative chemotherapy. However, these regimens suffer from poor patient compliance, particularly in the postoperative phase of treatment. The CRITICS-II trial aims to optimize preoperative treatment by comparing three treatment regimens: (1) chemotherapy, (2) chemotherapy followed by chemoradiotherapy and (3) chemoradiotherapy.

methodsIn this multicentre phase II non-comparative study, patients with clinical stage IB-IIIC (TNM 8th edition) resectable gastric adenocarcinoma are randomised between: (1) 4 cycles of docetaxel+oxaliplatin+capecitabine (DOC), (2) 2 cycles of DOC followed by chemoradiotherapy (45Gy in combination with weekly paclitaxel and carboplatin) or (3) chemoradiotherapy. Primary endpoint is event-free survival, 1 year after randomisation (events are local and/or regional recurrence or progression, distant recurrence, or death from any cause). Secondary endpoints include: toxicity, surgical outcomes, percentage radical (R0) resections, pathological tumour response, disease recurrence, overall survival, and health related quality of life. Exploratory endpoints include translational studies on predictive and prognostic biomarkers. DISCUSSION: The aim of this study is to select the most promising among three preoperative treatment arms in patients with resectable gastric adenocarcinoma. This treatment regimen will subsequently be compared with the standard therapy in a phase III trial.

trial registrationclinicaltrials.gov NCT02931890 ; registered 13 October 2016. Date of first enrolment: 21 December 2017.

Indexed as

Chemoradiotherapy, AdjuvantChemotherapy, AdjuvantGastrectomyNeoadjuvant TherapyAntineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyFemaleFollow-Up StudiesHumansMaleNeoplasm GradingNeoplasm MetastasisNeoplasm StagingQuality of LifeStomach NeoplasmsTreatment OutcomeChemoradiotherapyChemotherapyGastric cancerPreoperative treatmentResectableSurgery

Identifiers

PMID30200910
PMCPMC6131797

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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.