Evidence map›Paper›PMID 31470902›Full record

ArticleTrials2019

Therapy of nodal Follicular Lymphoma (WHO grade 1/2) in clinical stage I/II using response adapted Involved Site Radiotherapy in combination with Obinutuzumab (Gazyvaro) - GAZAI Trial (GAZyvaro and response adapted Involved-site Radiotherapy): a study protocol for a single-arm, non-randomized, open, national, multi-center phase II trial.

Laila König, Martin Dreyling, Jan Dürig, Marianne Engelhard, Karin Hohloch, Andreas Viardot, Mathias Witzens-Harig, Meinhard Kieser, Wolfram Klapper, Christiane Pott and 1 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. 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 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

NCT03341520 phase2completednot on this map

Therapy of Nodal Follicular Lymphoma (WHO Grade 1/2) in Clinical Stage I/II Using Response Adapted Involved Site Radiotherapy in Combination With Gazyvaro

TypeinterventionalSponsorHeidelberg UniversityRan2018 to 2024Enrolled89ConditionsStage II Grade 1 Follicular Lymphoma, Stage II Grade 2 Follicular Lymphoma, Stage I Follicular Lymphoma Grade 1, Stage II Follicular Lymphoma Grade 2ArmsObinutuzumab Injection [Gazyva], Low dose radiation Therapy (LDRT)
NCT05045664 phase3recruitingnot on this mapstarted 2022, after this paper: background citation

Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody

TypeinterventionalSponsorHeidelberg UniversityRan2022 to 2030Enrolled100ConditionsEarly Stage Follicular Lymphoma WHO Grade 1/2 or 3aArmsStandard, Experimental
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 20 citations in OpenAlex.

  1. PET/CT-based target volume definition in involved-site radiotherapy for treatment of early-stage nodal follicular lymphoma.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2025
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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

11 authors at 7 institutions in 2 countries.

Laila KönigDepartment of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. laila.koenig@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0001-8402-6694
Martin DreylingDepartment of Medicine III, University Hospital, Ludwig-Maximilians-University, Munich, Germany.
Jan DürigDepartment of Hematology, University of Essen, Essen, Germany.
Marianne EngelhardDepartment of Radiotherapy, University Hospital of Essen, Essen, Germany.
Karin HohlochDepartment of Hematology and Oncology, Kantonspital Graubünden, CH-7000, Chur, Switzerland.
Andreas ViardotDepartment of Internal Medicine III, University Hospital Ulm, Ulm, Germany.
Mathias Witzens-HarigDepartment of Hematology, Oncology and Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.
Meinhard KieserInstitute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
Wolfram KlapperDepartment of Pathology, Hematopathology Section and Lymph Node Registry, University of Kiel and University Medical Center Schleswig-Holstein, Kiel, Germany.
Christiane PottDepartment of Medicine 2, University Hospital Schleswig-Holstein, Kiel, Germany.
Klaus HerfarthDepartment of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Heidelberg University · DEEssen University Hospital · DEKantonsspital Graubünden · CHLudwig-Maximilians-Universität München · DEUniversity Hospital Schleswig-Holstein · DEUniversity Hospital Ulm · DEUniversity of Duisburg-Essen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLarge field irradiation had been standard for early-stage follicular lymphoma (FL) for a long time. Although involved field radiotherapy (IF-RT) was recently favored because of the toxicity of large field irradiation, smaller irradiation fields have been accompanied with an increased risk of out-of-field recurrence. The MIR (MabThera METHODS/

designThe GAZAI trial is a non-randomized, open, non-controlled, German, multi-center phase II trial that includes patients with early-stage (I and II) nodular FL (grades 1 and 2) confirmed by central histological review. A maximum of 93 patients will be included in the trial. Patients will receive a combined approach of immunotherapy with the fully humanized anti-CD20 antibody obinutuzumab (Gazyvaro DISCUSSION: The goal of this trial is a further reduction of the radiation dose in patients with nodal early-stage FL showing a good response to a combination of LDRT and anti-CD20 immunotherapy and a comparison with the currently published MIR trial.

trial registrationEudraCT number: 2016-002059-89. ClinicalTrials.gov identifier: NCT03341520 .

Indexed as

Antibodies, Monoclonal, HumanizedLymphoma, FollicularClinical Trials, Phase II as TopicCombined Modality TherapyHumansMulticenter Studies as TopicNeoplasm StagingPositron Emission Tomography Computed TomographyProspective StudiesResearch DesignAntibodies, Monoclonal, HumanizedobinutuzumabAnti-CD20 antibodyFollicular lymphomaInvolved site radiotherapyLow-dose radiotherapyObinutuzumabPET/CT

Identifiers

PMID31470902
PMCPMC6717383
OpenAlexW2970348319

What OpenQuestion holds

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LicenceCC BY
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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.