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PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Summary
In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2022-10-27
Completion Date
2028-04
Last Updated
2023-11-03
Healthy Volunteers
No
Interventions
Prophylactic cranial irradiation
Prophylactic cranial irradiation (PCI) is a technique used to combat the occurrence of metastasis to the brain in highly aggressive cancers that commonly metastasize to brain, most notably small-cell lung cancer.
Locations (41)
Medical University of Graz - Radio-oncology
Graz, Austria
Institut Jules Bordet
Anderlecht, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
AZ Groeninge Kortrijk - Campus Kennedylaan
Kortrijk, Belgium
C.H.U. Sart-Tilman
Liège, Belgium
Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus
Wilrijk, Belgium
Institut Sainte Catherine (UNICANCER)
Avignon, France
Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER)
Bayonne, France
Institut Bergonie (UNICANCER)
Bordeaux, France
Centre Francois Baclesse (CLCC) (UNICANCER)
Caen, France
CHU de Dijon - Centre Georges-Francois-Leclerc (UNICANCER)
Dijon, France
Centre Hospitalier Departemental Vendee (UNICANCER)
La Roche-sur-Yon, France
Institut Paoli-Calmettes (UNICANCER)
Marseille, France
Institut du Cancer de Montpellier (UNICANCER)
Montpellier, France
Centre Catalan d'Oncologie (UNICANCER)
Perpignan, France
CHU de Lyon - Hopital Lyon Sud (UNICANCER)
Pierre-Bénite, France
Centre Henri Becquerel (UNICANCER)
Rouen, France
Institut de Cancerologie Strasbourg Europe (UNICANCER)
Strasbourg, France
Gustave Roussy (UNICANCER)
Villejuif, France
Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH
Aachen, Germany
IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST
Genova, Italy
ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
Legnago, Italy
Fondazione IRCCS - Policlinico San Matteo
Pavia, Italy
ASST-Bergamo Ospedale Treviglio-Caravaggio
Treviglio, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, Italy
Medical University Of Gdansk
Gdansk, Poland
Regional Cancer Centre
Olsztyn, Poland
Hospital Universitario Badajoz
Badajoz, Spain
Hospital Insular De Gran Canaria
Las Palmas de Gran Canaria, Spain
Hospital Universitario Puerta De Hierro
Majadahonda, Spain
Inselspital
Bern, Switzerland
Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds
La Chaux-de-Fonds, Switzerland
Kantonsspital St Gallen
Sankt Gallen, Switzerland
UniversitaetsSpital Zurich
Zurich, Switzerland
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
Bristol, United Kingdom
NHS Lothian - Western General Hospital
Edinburgh, United Kingdom
Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital
Maidstone, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
Sheffield, United Kingdom
Royal Marsden Hospital - Sutton
Sutton, United Kingdom