Evidence map›Paper›PMID 26224039›Full record

Trial reportJournal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract2015

Neoadjuvant Chemoradiotherapy and Surgery Versus Surgery Alone in Resectable Pancreatic Cancer: A Single-Center Prospective, Randomized, Controlled Trial Which Failed to Achieve Accrual Targets.

Riccardo Casadei, Mariacristina Di Marco, Claudio Ricci, Donatella Santini, Carla Serra, Lucia Calculli, Marielda D'Ambra, Alessandra Guido, Antonio Maria Morselli-Labate, Francesco Minni

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07081360 (Neoadjuvant Chemotherapy Followed by Surgery Versus Upfront Surgery for Clearly Resectable Pancreatic Head Cancer and Periampullary Cancer), which is not on this map. Cited by 99 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 17 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.

NCT07081360 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

Neoadjuvant Chemotherapy Followed by Surgery Versus Upfront Surgery for Clearly Resectable Pancreatic Head Cancer and Periampullary Cancer: A Randomized Controlled Trial

TypeinterventionalSponsorMinia UniversityRan2025 to 2028Enrolled262ConditionsPancreas Cancer, Periampullary Cancer, Periampullary Carcinoma Resectable, Pancreatic Cancer ResectableArmsNeoadjuvant chemotherapy, Upfront Surgery Group
3 · Its place in the literature

Who cites it

99 citing papers in PubMed, 17 syntheses or guidelines pooled it.

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  13. Is Complete Pathologic Response in Pancreatic Cancer Overestimated? A Systematic Review of Prospective Studies.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2020
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39 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

10 authors.

Riccardo CasadeiDipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy. riccardo.casadei@aosp.bo.it.
Mariacristina Di MarcoDipartimento di Medicina Specialistica, Diagnostica e Sperimentale (DIMES), Oncologia Medica-Biasco, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
Claudio RicciDipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
Donatella SantiniAnatomia Patologica-Grigioni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
Carla SerraMedicina Interna-Morelli, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
Lucia CalculliRadiologia-Zompatori, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
Marielda D'AmbraDipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
Alessandra GuidoRadioterapia-Zompatori, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
Antonio Maria Morselli-LabateDipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
Francesco MinniDipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe objective of the study is to evaluate the usefulness of neoadjuvant chemoradiotherapy in resectable pancreatic cancer.

methodsA single-center RCT of patients affected by resectable pancreatic adenocarcinoma which included arm A (surgery alone) and arm B (neoadjuvant chemoradiation and surgery). The primary endpoint was R0 resection; the secondary endpoints were toxicity; number of patients who completed the neoadjuvant therapy; radiological and pathological response after chemoradiation; and pTNM stage, postoperative morbidity, mortality, and overall and disease-free survival. A sample size of 32 patients was required for each group.

resultsThe study was terminated early, and 38 patients were randomized: 20 in arm A and 18 in arm B. There was no significant difference regarding R0 resection rate in the two groups (intention-to-treat, OR = 1.91, P = 0.489). Neoadjuvant chemoradiotherapy was completed in 14 out of 18 cases (77.8 %) and the radiological and pathological response was efficacious in 72.3 and 90.9 % of cases, respectively.

conclusionsNeoadjuvant chemoradiation was feasible, safe, and efficacious, although non-significant results were obtained as a result of the underpowered data due to the difficulty in recruiting patients. Additional multicenter RCTs are needed in the future.

Indexed as

AdenocarcinomaAgedChemoradiotherapy, AdjuvantDisease-Free SurvivalFemaleHumansItalyMaleMiddle AgedPancreatectomyPancreatic NeoplasmsProspective StudiesSurvival RateTreatment OutcomeChemoradiotherapyPancreatic cancerPancreatic resection

Identifiers

PMID26224039

What OpenQuestion holds

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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.