EORTC-08112-LCG

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Nintedanib as maintenance treatment of malignant pleural mesothelioma (NEMO): a double-blind randomized phase II study of the EORTC Lung Cancer Group

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 05-Feb-2018 Date Step1 close: 03-Feb-2021
Data management at EORTC	Yes
Design	Phase 2 Randomized open label
Targeted Sample size	EORTC Groups: 116 - All Groups: 116
Treatment	Drug Nintedanib, blind trial medication-08112
Study Staff	Sanjay Popat (Study Coordinator) , Royal Marsden Hospital - Chelsea, London, London Omar Abdel-Rahman (Y-ECI Coordinator) , Ain Shams University Hospital, Cairo Hadi Almidani (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Catherine Fortpied (Unblinded statistician) , EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Joanna Krzystyniak (Clinical Operations Manager) , EORTC Headquarters, Brussels Eleni Mandila (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Sandrine Marreaud (Unblinded CRP) , EORTC Headquarters, Brussels Ana Oliveira (Data Manager) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Eliza Starczewska (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Yuliya Vostrikova (Clinical Data Expert) , EORTC Headquarters, Brussels
Type of cancer	Mesothelioma
Participating groups	EORTC Lung Cancer Group
Recruiting centers	AUSL Della Romagna -Ospedale Santa Maria delle Croci (Ravenna, Italy) Azienda Sociosanitaria Territoriale Santi Paolo E Carlo (Milano, Italy) CHU de Grenoble - La Tronche - Hopital A. Michallon (GRENOBLE CEDEX 9, France) East and North Hertfordshire NHS Trust – Mount Vernon Hospital (Northwood, United Kingdom) Kingston Hospital NHS trust (Kingston upon Thames, United Kingdom) Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital (Maidstone, United Kingdom) NHS South Tyneside-South Tyneside District Hospital (Tyne and Wear, United Kingdom) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) Royal Marsden Hospital - Sutton, Surrey (Surrey, United Kingdom) Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom) Somerset NHS Foundation Trust-Musgrove Park Hospital (Somerset, United Kingdom) Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) Universitair Ziekenhuis Gent (Gent, Belgium) Wythenshawe Hospital (MFT) (Wythenshawe, Manchester, United Kingdom)
Protocol summary	http://clinicaltrials.gov/study/NCT02863055
NCT number	NCT02863055
EudraCT	2016-000521-38
Financial Support	Educational Grant