Spots Global Cancer Trial Database for PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
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Trial Identification
Brief Title: PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
Official Title: PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
Study ID: NCT04790253
Interventions
Study Description
Brief 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.
Detailed Description: 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 under the treatment policy strategy. The secondary objectives are: * To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of cognitive failure free survival (CFFS) compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. * To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of global health status/QoL and cognitive functioning according to EORTC QLQ-C30 questionnaire compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. * To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the two arms in the treated population (i.e. patients who have started treatment). The exploratory objectives are: * To compare OS and CFFS between the arms within the subgroups of patients with LS and ES disease. * To compare OS and CFFS between the arms within the subgroups: HA-PCI or not, first-line immunotherapy or not, memantine or not. * To compare cognitive failure free survival (CFFS) rate at 12 months after randomization between the arms. * To compare the cumulative incidence of cognitive failures with death as a competing risk between the arms. * To compare brain-metastasis-free survival (BMFS) between the arms. * To compare progression free survival (PFS) between the arms. * To compare time to brain-metastasis-attributed death (TBMAD) between the arms. * To compare other QoL scales according to EORTC QLQ-C30 and QLQ-BN20 questionnaires between arms. * To evaluate the cost-effectiveness of MRI surveillance alone versus MRI surveillance combined with PCI. * To collect blood for biobanking.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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 Benite Cedex, , 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, Gdańsk, , 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, Saint Gallen, , Switzerland
UniversitaetsSpital Zurich, Zürich, , 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
Contact Details
Name: Corinne Faivre-Finn, MD
Affiliation: The Christie NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR
Name: Antonin Levy, MD
Affiliation: Centre Gustave Roussy
Role: PRINCIPAL_INVESTIGATOR
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