Evidence map›Paper›PMID 25884448›Full record

Trial reportBMC cancer2015

Neo-adjuvant chemotherapy followed by surgery versus surgery alone in high-risk patients with resectable colorectal liver metastases: the CHARISMA randomized multicenter clinical trial.

Ninos Ayez, Eric P van der Stok, Hans de Wilt, Sandra A Radema, Richard van Hillegersberg, Rudi M Roumen, Gerard Vreugdenhil, Pieter J Tanis, Cornelis J Punt, Cornelis H Dejong and 12 more

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 11% 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.

  1. Pooled it
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  5. SEOM-GEMCAD-TTD clinical guidelines for the systemic treatment of metastatic colorectal cancer (2022).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
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  7. Review
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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 at 10 institutions in 1 country.

Ninos AyezDepartment of Surgical Oncology, Erasmus MC Cancer Institute, Groene Hilledijk 301, 3075 EA, Rotterdam, The Netherlands. n.ayez@erasmusmc.nl.
Eric P van der StokDepartment of Surgical Oncology, Erasmus MC Cancer Institute, Groene Hilledijk 301, 3075 EA, Rotterdam, The Netherlands. e.vanderstok@erasmusmc.nl.
Hans de WiltDepartment of Surgical Oncology, Radboud University, Nijmegen Medical Center, Nijmegen, The Netherlands. hans.dewilt@radboudumc.nl.
Sandra A RademaDepartment of Medical Oncology, Radboud University, Nijmegen Medical Center, Nijmegen, The Netherlands. sandra.radema@radboudumc.nl.
Richard van HillegersbergDepartment of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands. r.vanhillegersberg@umcutrecht.nl.
Rudi M RoumenDepartment of Surgery, Máxima Medical Center, Veldhoven, The Netherlands. r.roumen@mmc.nl.
Gerard VreugdenhilDepartment of Medical Oncology, Máxima Medical Center, Veldhoven, The Netherlands. g.vreugdenhil@mmc.nl.
Pieter J TanisDepartment of Surgery, Academic Medical Center, Amsterdam, The Netherlands. p.j.tanis@amc.nl.
Cornelis J PuntDepartment of Medical Oncology, Academic Medical Center, Amsterdam, The Netherlands. c.punt@amc.uva.nl.
Cornelis H DejongDepartment of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. chc.dejong@mumc.nl.
Rob L JansenDepartment of Medical Oncology, Maastricht University Medical Center, Maastricht, The Netherlands. rob.jansen@mumc.nl.
Henk M VerheulDepartment of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands. h.verheul@vumc.nl.
Koert P de JongDivision of Hepato-Pancreato-Biliary Surgery and Liver Transplantation, Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. k.p.de.jong@umcg.nl.
Geke A HospersDepartment of Medical Oncology, University Medical Center Groningen, Groningen, The Netherlands. g.a.p.hospers@umcg.nl.
Joost M KlaaseDepartment of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands. j.klaase@mst.nl.
Marie-Cecile LegdeurDepartment of Internal Medicine, Medisch Spectrum Twente, Enschede, The Netherlands. m.legdeur@mst.nl.
Esther van MeertenDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. e.vanmeerten@erasmusmc.nl.
Ferry A EskensDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. f.eskens@erasmusmc.nl.
Nelly van der MeerClinical Trial Center, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. n.vandermeer@erasmusmc.nl.
Bruno van der HoltClinical Trial Center, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. b.vanderholt@erasmusmc.nl.
Cornelis VerhoefDepartment of Surgical Oncology, Erasmus MC Cancer Institute, Groene Hilledijk 301, 3075 EA, Rotterdam, The Netherlands. c.verhoef@erasmusmc.nl.
Dirk J GrünhagenDepartment of Surgical Oncology, Erasmus MC Cancer Institute, Groene Hilledijk 301, 3075 EA, Rotterdam, The Netherlands. d.grunhagen@erasmusmc.nl.
Erasmus University Rotterdam · NLAcademic Medical Center · NLErasmus MC Cancer Institute · NLMaastricht University · NLMáxima Medisch Centrum · NLMedisch Spectrum Twente · NLRadboud University Nijmegen · NLUniversity Medical Center Groningen · NLAmsterdam UMC Location VUmc · NLUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEfforts to improve the outcome of liver surgery by combining curative resection with chemotherapy have failed to demonstrate definite overall survival benefit. This may partly be due to the fact that these studies often involve strict inclusion criteria. Consequently, patients with a high risk profile as characterized by Fong's Clinical Risk Score (CRS) are often underrepresented in these studies. Conceptually, this group of patients might benefit the most from chemotherapy. The present study evaluates the impact of neo-adjuvant chemotherapy in high-risk patients with primary resectable colorectal liver metastases, without extrahepatic disease. Our hypothesis is that adding neo-adjuvant chemotherapy to surgery will provide an improvement in overall survival (OS) in patients with a high-risk profile. METHODS/

designCHARISMA is a multicenter, randomized, phase III clinical trial. Patients will be randomized to either surgery alone (standard treatment, arm A) or to 6 cycles of neo-adjuvant oxaliplatin-based chemotherapy, followed by surgery (arm B). Patients must be ≥ 18 years of age with liver metastases of histologically confirmed primary colorectal carcinoma. Patients with extrahepatic metastases are excluded. Liver metastases must be deemed primarily resectable. Only patients with a CRS of 3-5 are eligible. The primary study endpoint is OS. Secondary endpoints are progression free survival (PFS), quality of life, morbidity of resection, treatment response on neo-adjuvant chemotherapy, and whether CEA levels can predict treatment response. DISCUSSION: CHARISMA is a multicenter, randomized, phase III clinical trial that will provide an answer to the question if adding neo-adjuvant chemotherapy to surgery will improve OS in a well-defined high-risk patient group with colorectal liver metastases.

trial registrationThe CHARISMA is registered at European Union Clinical Trials Register (EudraCT), number: 2013-004952-39 , and in the "Netherlands national Trial Register (NTR), number: 4893.

Indexed as

Neoadjuvant TherapyAdultAgedColorectal NeoplasmsCombined Modality TherapyDigestive System Surgical ProceduresDisease-Free SurvivalFemaleHumansLiver NeoplasmsMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinRisk FactorsOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID25884448
PMCPMC4377036
OpenAlexW2008022518

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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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.