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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

Large 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-...

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Main Authors: König, Laila (Author) , Dreyling, Martin (Author) , Dürig, Jan (Author) , Engelhardt-Schagen, Marianne (Author) , Hohloch, Karin (Author) , Viardot, Andreas (Author) , Witzens-Harig, Mathias (Author) , Kieser, Meinhard (Author) , Klapper, Wolfram (Author) , Pott, Christiane (Author) , Herfarth, Klaus (Author)
Format: Article (Journal)
Language:English
Published: 30 August 2019
In: Trials
Year: 2019, Volume: 20, Pages: 1-8
ISSN:1468-6694
DOI:10.1186/s13063-019-3614-y
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1186/s13063-019-3614-y
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Author Notes:Laila König, Martin Dreyling, Jan Dürig, Marianne Engelhard, Karin Hohloch, Andreas Viardot, Mathias Witzens-Harig, Meinhard Kieser, Wolfram Klapper, Christiane Pott, and Klaus Herfarth
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Summary:Large 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® and Involved field Radiation) trial has shown that the combination of IF-RT at a dose of 30-40 Gy with the anti-CD20 antibody rituximab has led to similar efficacy compared with large field irradiation but with markedly reduced side effects. Immune modulating radiation therapy alone using low-dose radiotherapy (LDRT) of 2 × 2 Gy has been shown to be effective in FL. The GAZAI (GAZyvaro and response Adapted Involved-site Radiotherapy) trial aims to prove the efficacy of LDRT in combination with a novel anti-CD20 therapy.
Item Description:Gesehen am 15.04.2020
Physical Description:Online Resource
ISSN:1468-6694
DOI:10.1186/s13063-019-3614-y

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