Evidence map›Paper›PMID 33926539›Full record

ArticleTrials2021

Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial.

M S Walma, S J Rombouts, L J H Brada, I H Borel Rinkes, K Bosscha, R C Bruijnen, O R Busch, G J Creemers, F Daams, R M van Dam and 35 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03690323 (Pancreatic Locally Advanced Irresectable Cancer Ablation; a Randomized Controlled Superiority Phase III Multicenter Trial), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.3field-weighted citation impact, top 16% 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.

NCT03690323 naunknown statusnot on this map

Pancreatic Locally Advanced Irresectable Cancer Ablation; a Randomized Controlled Superiority Phase III Multicenter Trial

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2015 to 2020Enrolled228ConditionsLocally Advanced Pancreatic CancerArmsRadiofrequency ablation (RFA), FOLFIRINOX, Nab-paclitaxel plus Gemcitabine, Gemcitabine
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 18 citations in OpenAlex.

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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

45 authors at 13 institutions in 4 countries.

M S Walma *Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. m.s.walma@umcutrecht.nl.
S J Rombouts *Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
L J H Brada *Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
I H Borel RinkesDepartments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
K BosschaDepartments of Surgery and Medical Oncology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
R C BruijnenDepartments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
O R BuschDepartments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
G J CreemersDepartments of Surgery and Medical Oncology, Catharina Hospital, Eindhoven, The Netherlands.
F DaamsDepartments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
R M van DamDepartments of Surgery and Medical Oncology GROW - School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, The Netherlands.
O M van DeldenDepartments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
S FestenDepartments of Surgery and Medical Oncology, OLVG, Amsterdam, The Netherlands.
P GhorbaniPancreatic Surgery Unit, Division of Surgery, CLINTEC, Karolinska Institute at Center for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden.
D J de GrootDepartments of Surgery and Medical Oncology, UMC Groningen, Groningen, The Netherlands.
J W B de GrootDepartments of Surgery and Medical Oncology, Isala, Zwolle, The Netherlands.
N Haj MohammadDepartments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
R van HillegersbergDepartments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
I H de HinghDepartments of Surgery and Medical Oncology, Catharina Hospital, Eindhoven, The Netherlands.
M D'HondtDepartment of General and Digestive Surgery, Groeninge Hospital, Kortrijk, Belgium.
E D KerverDepartments of Surgery and Medical Oncology, OLVG, Amsterdam, The Netherlands.
M S van LeeuwenDepartments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
M S LiemDepartments of Surgery and Medical Oncology, Medical Spectrum Twente, Enschede, The Netherlands.
K P van LiendenDepartments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
M LosDepartments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
V E de MeijerDepartments of Surgery and Medical Oncology, UMC Groningen, Groningen, The Netherlands.
M R MeijerinkDepartments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
L J MekenkampDepartments of Surgery and Medical Oncology, Medical Spectrum Twente, Enschede, The Netherlands.
C Y NioDepartments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
I Oulad AbdennabiDepartments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
E PandoHBP Surgery and Transplant Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
G A PatijnDepartments of Surgery and Medical Oncology, Isala, Zwolle, The Netherlands.
M B PoléeDepartment of Medical Oncology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.
J F PruijtDepartments of Surgery and Medical Oncology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
G RoeyenDepartment of Hepatobiliary, Endocrine and Transplantation Surgery, Antwerp University Hospital, Antwerp, Belgium.
J A RopelaDepartment of Medical Oncology, St Jansdal Hospital, Harderwijk, The Netherlands.
M W J StommelDepartment of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.
J de Vos-GeelenDepartments of Surgery and Medical Oncology GROW - School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, The Netherlands.
J J de VriesDepartments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
E M van der WaalDepartments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
F J WesselsDepartments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
J W WilminkDepartments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
H C van Santvoort *Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
M G Besselink *Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
I Q Molenaar *Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. i.q.molenaar@umcutrecht.nl.
Dutch Pancreatic Cancer Group
Utrecht University · NLRadboud University Nijmegen · NLUniversity Medical Center Groningen · NLMaastricht University Medical Centre · NLMedisch Spectrum Twente · NLAntwerp University Hospital · BEMedisch Centrum Leeuwarden · NLVall d'Hebron Hospital Universitari · ESAmsterdam University Medical Centers · NLAZ Groeninge · BEKarolinska University Hospital · SEOLVG · NLUniversity Medical Center Utrecht · NL

Funding

KWF Kankerbestrijding 2014-7444
6 · The paper itself

Abstract

backgroundApproximately 80% of patients with locally advanced pancreatic cancer (LAPC) are treated with chemotherapy, of whom approximately 10% undergo a resection. Cohort studies investigating local tumor ablation with radiofrequency ablation (RFA) have reported a promising overall survival of 26-34 months when given in a multimodal setting. However, randomized controlled trials (RCTs) investigating the effect of RFA in combination with chemotherapy in patients with LAPC are lacking.

methodsThe "Pancreatic Locally Advanced Unresectable Cancer Ablation" (PELICAN) trial is an international multicenter superiority RCT, initiated by the Dutch Pancreatic Cancer Group (DPCG). All patients with LAPC according to DPCG criteria, who start with FOLFIRINOX or (nab-paclitaxel/)gemcitabine, are screened for eligibility. Restaging is performed after completion of four cycles of FOLFIRINOX or two cycles of (nab-paclitaxel/)gemcitabine (i.e., 2 months of treatment), and the results are assessed within a nationwide online expert panel. Eligible patients with RECIST stable disease or objective response, in whom resection is not feasible, are randomized to RFA followed by chemotherapy or chemotherapy alone. In total, 228 patients will be included in 16 centers in The Netherlands and four other European centers. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, RECIST response, CA 19.9 and CEA response, toxicity, quality of life, pain, costs, and immunomodulatory effects of RFA. DISCUSSION: The PELICAN RCT aims to assess whether the combination of chemotherapy and RFA improves the overall survival when compared to chemotherapy alone, in patients with LAPC with no progression of disease following 2 months of systemic treatment.

trial registrationDutch Trial Registry NL4997 . Registered on December 29, 2015. ClinicalTrials.gov NCT03690323 . Retrospectively registered on October 1, 2018.

Indexed as

Pancreatic NeoplasmsRadiofrequency AblationAntineoplastic Combined Chemotherapy ProtocolsEquivalence Trials as TopicHumansMulticenter Studies as TopicNetherlandsProgression-Free SurvivalRandomized Controlled Trials as TopicChemotherapyLocally advanced pancreatic cancerOverall survivalRadiofrequency ablation

Identifiers

PMID33926539
PMCPMC8082784
OpenAlexW3158728933

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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.