A randomized trial (RAREST-01) comparing Mepitel® Film and standard care for prevention of radiation dermatitis in patients irradiated for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN).


Journal

Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
ISSN: 1879-0887
Titre abrégé: Radiother Oncol
Pays: Ireland
ID NLM: 8407192

Informations de publication

Date de publication:
10 2019
Historique:
received: 16 05 2019
revised: 16 07 2019
accepted: 16 07 2019
pubmed: 23 8 2019
medline: 6 5 2020
entrez: 22 8 2019
Statut: ppublish

Résumé

Mepitel® Film (MEP) and standard care (STD) were compared for radiation dermatitis in SCCHN patients. This trial was stopped prematurely since13/28 patients did not tolerate MEP. Grade ≥2 dermatitis: 34.8% (MEP) vs. 35.7% (STD) at 50 Gy, 65.2% vs. 59.3% at 60 Gy. MEP was unsatisfactorily tolerated and appeared not superior (NCT03047174).

Identifiants

pubmed: 31431372
pii: S0167-8140(19)33016-6
doi: 10.1016/j.radonc.2019.07.023
pii:
doi:

Substances chimiques

Silicones 0
mepitel 0

Banques de données

ClinicalTrials.gov
['NCT03047174']

Types de publication

Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

79-82

Informations de copyright

Copyright © 2019 Elsevier B.V. All rights reserved.

Auteurs

Dirk Rades (D)

Department of Radiation Oncology, University of Luebeck, Germany. Electronic address: rades.dirk@gmx.net.

Carlos A Narvaez (CA)

Department of Radiation Oncology, University of Luebeck, Germany.

Laura Splettstößer (L)

Department of Radiation Oncology, University of Luebeck, Germany.

Claudia Dömer (C)

Department of Radiation Oncology, University of Luebeck, Germany.

Cornelia Setter (C)

Department of Radiation Oncology, Christian-Albrechts University Kiel, Germany.

Christian Idel (C)

Department of Radiation Oncology, University of Luebeck, Germany; Department of Radiation Oncology and Department of Oto-Rhino-Laryngology and Head and Neck Surgery, University of Luebeck, Germany.

Julika Ribbat-Idel (J)

Institute of Pathology, University Hospital Schleswig-Holstein, Luebeck, Germany.

Sven Perner (S)

Institute of Pathology, University Hospital Schleswig-Holstein, Luebeck, Germany; Pathology, Research Center Borstel, Leibniz Lung Center, Borstel, Germany.

Tobias Bartscht (T)

Department of Hematology & Medical Oncology, University of Luebeck, Germany.

Denise Olbrich (D)

Centre for Clinical Trials Luebeck, Germany.

Steven E Schild (SE)

Department of Radiation Oncology, Mayo Clinic, Scottsdale, USA.

Jesper Carl (J)

Department of Oncology & Palliative Units, Zealand University Hospital, Naestved, Denmark.

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Classifications MeSH