Evidence map›Paper›PMID 32533228›Full record

Trial reportStrahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]2020

Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2).

Dirk Rades, Tobias Bartscht, Peter Hunold, Heinz Schmidberger, Laila König, Jürgen Debus, Claus Belka, Nils Homann, Patrick Spillner, Cordula Petersen and 9 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01787006 (Definitive Radiochemotherapy With 5-FU / Cisplatin Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% 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.

NCT01787006 phase2completednot on this map

Definitive Radiochemotherapy With 5-FU / Cisplatin Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer: a Phase II Study

TypeinterventionalSponsorUniversity Hospital Schleswig-HolsteinRan2011 to 2018Enrolled74ConditionsEsophageal CancerArmsCetuximab, Cisplatin, 5-FU, Radiotherapy
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. 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

19 authors at 12 institutions in 3 countries.

Dirk RadesDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany. Rades.Dirk@gmx.net.
Tobias BartschtDepartment of Hematology and Oncology, University of Lübeck, Lübeck, Germany.
Peter HunoldDepartment of Radiology and Nuclear Medicine, University of Lübeck, Lübeck, Germany.
Heinz SchmidbergerDepartment of Radiation Oncology, Johannes-Gutenberg University Mainz, Mainz, Germany.
Laila KönigDepartment of Radiation Oncology, University of Heidelberg, Heidelberg, Germany.
Jürgen DebusDepartment of Radiation Oncology, University of Heidelberg, Heidelberg, Germany.
Claus BelkaDepartment of Radiation Oncology, Ludwig-Maximillians University, Munich, Germany.
Nils HomannMedical Department II, Klinikum Wolfsburg, Wolfsburg, Germany.
Patrick SpillnerDepartment of Radiation Oncology, Eberhard-Karls University, Tübingen, Germany.
Cordula PetersenDepartment of Radiotherapy and Radiation Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Thomas KuhntDepartment of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany.
Rainer FietkauDepartment of Radiation Oncology, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.
Karsten RidwelskiDepartment of General and Visceral Surgery, Klinikum Magdeburg, Magdeburg, Germany.
Kerstin Karcher-KilianPractice for Gastroenterology, Diabetology, Oncology and Hematology Lübeck, Lübeck, Germany.
Anne KranichGesellschaft für Studienmanagement und Onkologie mbH, Hamburg, Germany.
Sofia MännikköPharma Ltd, Turku, Finland.
Steven E SchildDepartment of Radiation Oncology, Mayo Clinic Scottsdale, AZ, USA.
Annett Maderer1st Department of Internal Medicine, Johannes Gutenberg-University Mainz, Mainz, Germany.
Markus Moehler1st Department of Internal Medicine, Johannes Gutenberg-University Mainz, Mainz, Germany.
University of Lübeck · DEJohannes Gutenberg University Mainz · DEHeidelberg University · DEFraunhofer Project Centre Wolfsburg · DEFriedrich-Alexander-Universität Erlangen-Nürnberg · DEKlinikum Magdeburg · DELudwig-Maximilians-Universität München · DEMayo Clinic in Arizona · USPharmatest (Finland) · FIUniversität Hamburg · DEUniversity Hospital Leipzig · DEUniversity of Tübingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate the efficacy and toxicity of cetuximab when added to radiochemotherapy for unresectable esophageal cancer.

methodsThis randomized phase 2 trial (clinicaltrials.gov, identifier NCT01787006) compared radiochemotherapy plus cetuximab (arm A) to radiochemotherapy (arm B) for unresectable esophageal cancer. Primary objective was 2‑year overall survival (OS). Arm A was considered insufficiently active if 2‑year OS was ≤40% (null hypothesis = H

resultsTwo-year OS was 71% in arm A (95% CI: 55-87%) vs. 53% in arm B (95% CI: 36-71%); H

conclusionGiven the limitations of this trial, radiochemotherapy plus cetuximab was feasible. There was a trend towards improved PFS and MFS. Larger studies are required to better define the role of cetuximab for unresectable esophageal cancer.

Indexed as

ChemoradiotherapyAdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalCetuximabDisease-Free SurvivalEsophageal NeoplasmsFemaleHumansMaleMiddle AgedProgression-Free SurvivalAntineoplastic Agents, ImmunologicalCetuximabDefinitive treatmentEfficacyEGFR antibodyEsophageal cancerFeasibility

Identifiers

PMID32533228
PMCPMC7449950
OpenAlexW3035422823

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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.