Evidence map›Paper›PMID 37686537›Full record

ArticleCancers2023

Failure of a Multi-Centric Clinical Trial Investigating Neoadjuvant Radio-Chemotherapy in Resectable Pancreatic Carcinoma (NEOPA-NCT01900327)-Which Lessons Are Learnt?

Michael Tachezy, Florian Gebauer, Emre Yekebas, Jakob Robert Izbicki

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Cancers, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01900327 (Sequential Neoadjuvant Chemoradiotherapy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 56% 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.

NCT01900327 phase3terminatednot on this map

Sequential Neoadjuvant Chemoradiotherapy (CRT) Followed by Curative Surgery vs. Primary Surgery Alone for Resectable, Non-metastasized Pancreatic Adenocarcinoma

TypeinterventionalSponsorUniversitätsklinikum Hamburg-EppendorfRan2014 to 2017Enrolled32ConditionsPancreatic CancerArmsExternal Beam Radiation, Gemcitabine neoadjuvant, Surgery, Gemcitabine adjuvant
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 0 citations in OpenAlex.

  1. Review
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

4 authors at 3 institutions in 1 country.

Michael TachezyDepartment of General, Visceral and Thoracic Surgery, University-Hospital Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
Florian GebauerDepartment of General, Visceral and Thoracic Surgery, University-Hospital Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
Emre YekebasDepartment of General, Visceral and Thoracic Surgery, University-Hospital Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
Jakob Robert IzbickiDepartment of General, Visceral and Thoracic Surgery, University-Hospital Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
Universität Hamburg · DEHelios Universitätsklinikum Wuppertal · DEUniversity Medical Center Hamburg-Eppendorf · DE

Funding

German Federal Ministry of Education and Research (Bundeministerium für Bildung und Forschung) 01KG1208
6 · The paper itself

Abstract

backgroundA significant number of clinical trials must be prematurely discontinued due to recruitment failure, and only a small fraction publish results and a failure analysis. Based on our experience on conducting the NEOPA trial on neoadjuvant radiochemotherapy for resectable and borderline resectable pancreatic carcinoma (NCT01900327-funded by the German Federal Ministry of Education and Research-BMBF), we performed an analysis of potential reasons for recruitment failure and general problems in conducting clinical trials in Germany.

methodsSystematic analysis of environmental factors, trial history, conducting and funding in the background of the published literature.

resultsThe recruitment failure was based on various study-specific conceptional and local environmental aspects and in peculiarities of the German surgical study culture. General reservations against a neo-adjuvant study concept combined with game changing scientific progresses during the long-lasting planning and funding phase have led to a reduced interest in the trial design and recruitment.

conclusionsTrial planning and conducting should be focused, professionalized and financed on a national basis. Individual interests must be subordinated to reach the goal to perform more relevant and successful clinical trials in Germany. Bureaucratic processes must be further fastened between a trial idea and the start of a study.

Indexed as

neoadjuvant therapypancreatic cancerprospective randomized trialradio-chemotherapy

Identifiers

PMID37686537
PMCPMC10487154
OpenAlexW4386168114

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.