Evidence map›Paper›PMID 25252602›Full record

Trial reportStrahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]2015

Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer: results of the first prospective randomized phase II trial.

Henriette Golcher, Thomas B Brunner, Helmut Witzigmann, Lukas Marti, Wolf-Otto Bechstein, Christiane Bruns, Henry Jungnickel, Stefan Schreiber, Gerhard G Grabenbauer, Thomas Meyer and 3 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 144 papers, 24 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
144citing papers in PubMed, 24 pooled it
10.3field-weighted citation impact, top 1% 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.

NCT00335543 phase2completednot on this map

Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis

TypeinterventionalSponsorInterdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen KrebsgesellschaftRan2003 to 2009Enrolled254ConditionsPancreatic CancerArmscisplatin, gemcitabine hydrochloride, adjuvant therapy, conventional surgery, neoadjuvant therapy
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

144 citing papers in PubMed, 24 syntheses or guidelines pooled it, 327 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. 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
    Pooled it
  13. Pooled it
  14. Pooled it
  15. Pooled it
  16. Pooled it
  17. Pooled it
  18. Pooled it
  19. Pooled it
  20. Pooled it

84 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

13 authors at 9 institutions in 2 countries.

Henriette GolcherDepartment of Surgery, University Hospital Erlangen, Krankenhausstr. 12, 91054, Erlangen, Germany, henriette.golcher@uk-erlangen.de.
Thomas B Brunner
Helmut Witzigmann
Lukas Marti
Wolf-Otto Bechstein
Christiane Bruns
Henry Jungnickel
Stefan Schreiber
Gerhard G Grabenbauer
Thomas Meyer
Susanne Merkel
Rainer Fietkau
Werner Hohenberger
Universitätsklinikum Erlangen · DEUniversity Hospital Leipzig · DEAnsbach University of Applied Sciences · DEKantonsspital St. Gallen · CHKlinikum Coburg · DEKrankenhaus Dresden-Friedrichstadt · DEMünchen Klinik · DEUniversity Hospital Frankfurt · DEUniversity Medical Center Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging. PATIENTS AND

methodsPatients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS).

resultsThe trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48% (A) and 52% (B, P = 0.81) and (y)pN0 was 30% (A) vs. 39% (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79).

conclusionThis worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543.

Indexed as

AdultAgedAge DistributionAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapy, AdjuvantCisplatinDeoxycytidineFemaleGemcitabineGermanyHumansMaleMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalPancreatectomyCisplatinDeoxycytidineGemcitabine

Identifiers

PMID25252602
PMCPMC4289008
OpenAlexW592682419

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.