RecruitingNot ApplicableNCT04790253

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

Enrollment

600 participants

Start Date

Oct 27, 2022

Study Type

INTERVENTIONAL

Conditions

Limited Stage Small Cell Lung Cancer Extensive-stage Small-cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for people with small-cell lung cancer (SCLC) who have responded to initial treatment: preventive brain radiation (a standard treatment to stop cancer from spreading to the brain) versus regular MRI brain scans to closely monitor for any spread without treating prophylactically. Researchers want to know which approach preserves quality of life and survival better. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of small-cell lung cancer (SCLC), either limited or extensive stage - Your cancer has responded to initial treatment - You are fit enough to receive radiation if assigned to that group **You may NOT be eligible if...** - Your cancer has already spread to the brain - You cannot undergo MRI scans - You are in very poor health - You do not meet other protocol-specific criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProphylactic 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

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NCT04790253

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