Evidence map›Paper›PMID 24906700›Full record

Trial reportBMC cancer2014

Sequential neoadjuvant chemoradiotherapy (CRT) followed by curative surgery vs. primary surgery alone for resectable, non-metastasized pancreatic adenocarcinoma: NEOPA- a randomized multicenter phase III study (NCT01900327, DRKS00003893, ISRCTN82191749).

Michael Tachezy, Florian Gebauer, Cordula Petersen, Dirk Arnold, Martin Trepel, Karl Wegscheider, Phillipe Schafhausen, Maximilian Bockhorn, Jakob Robert Izbicki, Emre Yekebas

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2014. 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 34 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 5 pooled it
4.8field-weighted citation impact, top 4% 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

34 citing papers in PubMed, 5 syntheses or guidelines pooled it, 81 citations in OpenAlex.

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  9. Total neoadjuvant therapy for pancreatic adenocarcinoma increases probability for a complete pathologic response.European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology · 2022
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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

10 authors at 3 institutions in 1 country.

Michael Tachezy
Florian Gebauer
Cordula Petersen
Dirk Arnold
Martin Trepel
Karl Wegscheider
Phillipe Schafhausen
Maximilian Bockhorn
Jakob Robert IzbickiDepartment of General, Visceral and Thoracic Surgery, University Medical Center Hamburg Eppendorf, Martinistr, 52, Hamburg 20246, Germany. izbicki@uke.de.
Emre Yekebas
University Medical Center Hamburg-Eppendorf · DEUniversität Hamburg · DEUniversity Cancer Center Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMedian OS after surgery in curative intent for non-metastasized pancreas cancer ranges under study conditions from 17.9 months to 23.6 months. Tumor recurrence occurs locally, at distant sites (liver, peritoneum, lungs), or both. Observational and autopsy series report local recurrence rates of up to 87% even after potentially "curative" R0 resection. To achieve better local control, neoadjuvant CRT has been suggested for preoperative tumour downsizing, to elevate the likelihood of curative, margin-negative R0 resection and to increase the OS rate. However, controlled, randomized trials addressing the impact of neoadjuvant CRT survival do not exist. METHODS/

designThe underlying hypothesis of this randomized, two-armed, open-label, multicenter, phase III trial is that neoadjuvant CRT increases the three-year overall survival by 12% compared to patients undergoing upfront surgery for resectable pancreatic cancer. A rigorous, standardized technique of histopathologically handling Whipple specimens will be applied at all participating centers. Overall, 410 patients (n=205 in each study arm) will be enrolled in the trial, taking into regard an expected drop out rate of 7% and allocated either to receive neoadjuvant CRT prior to surgery or to undergo surgery alone. Circumferential resection margin status, i.e. R0 and R1 rates, respectively, surgical resectability rate, local and distant disease-free and global survival, and first site of tumor recurrence constitute further essential endpoints of the trial. DISCUSSION: For the first time, the NEOPA study investigates the impact of neoadjuvant CRT on survival of resectable pancreas head cancer in a prospectively randomized manner. The results of the study have the potential to change substantially the treatment regimen of pancreas cancer.

trial registrationClinical Trial gov: NCT01900327, DRKS00003893, ISRCTN82191749.

Indexed as

Chemoradiotherapy, AdjuvantAdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyCombined Modality TherapyDisease-Free SurvivalFemaleHumansMaleMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalPancreatic Neoplasms

Identifiers

PMID24906700
PMCPMC4057592
OpenAlexW2082012394

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.