Actively Recruiting
PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2023-11-03
600
Participants Needed
41
Research Sites
283 weeks
Total Duration
On this page
Sponsors
E
European Organisation for Research and Treatment of Cancer - EORTC
Lead Sponsor
U
UNICANCER
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of small cell lung cancer confirmed by tissue or cell analysis
- Limited stage (Stage I-III) or extensive stage (Stage IV) disease
- For limited stage: tumor can be treated safely with radiation
- Completed standard therapy including 4-6 cycles of platinum-based chemotherapy and definitive thoracic radiotherapy or surgery for limited stage
- Completed 4-6 cycles of platinum-based chemotherapy with or without thoracic radiotherapy for extensive stage
- No disease progression on recent imaging within 28 days before randomization
- No brain metastases or leptomeningeal disease on recent imaging within 28 days before randomization
- Randomization within 8 weeks after last chemotherapy cycle
- ECOG performance status 0 to 2
- Estimated creatinine clearance of at least 30 mL/min
- Negative pregnancy test for women of childbearing potential within 3 days before randomization
- Women of childbearing potential must use effective birth control during treatment and for 30 days after
- Breastfeeding women must stop nursing before and during radiotherapy until 30 days after last dose
- Willing and able to follow study procedures and visits
- Provided written informed consent
You will not qualify if you...
- Prior brain radiotherapy or whole brain radiotherapy (except some benign tumor treatments considered case-by-case)
- Allergy or contraindication to contrast media or MRI (such as metal implants)
- Other active cancers requiring treatment
- Unresolved severe side effects from prior therapy above grade 2
- Severe heart conditions like unstable angina or recent heart attack within 6 months
- Acute infections requiring treatment
- Acute respiratory illness preventing study treatment
- Severe liver disease (Child-Pugh class B or C)
- HIV positive with low CD4 count under 200 cells/microliter (unless on therapy and CD4 count is adequate)
- Any other severe medical condition that may interfere with study participation
- Severe neurological or psychiatric disorders requiring treatment
- Conditions that might prevent following study protocol or visits such as social or geographic issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 41 locations
1
Medical University of Graz - Radio-oncology
Graz, Austria, 8036
Actively Recruiting
2
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
3
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
4
AZ Groeninge Kortrijk - Campus Kennedylaan
Kortrijk, Belgium, 8500
Actively Recruiting
5
C.H.U. Sart-Tilman
Liège, Belgium, 4000
Actively Recruiting
6
Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus
Wilrijk, Belgium, 2610
Actively Recruiting
7
Institut Sainte Catherine (UNICANCER)
Avignon, France, 84918
Actively Recruiting
8
Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER)
Bayonne, France, 64100
Actively Recruiting
9
Institut Bergonie (UNICANCER)
Bordeaux, France, 33067
Actively Recruiting
10
Centre Francois Baclesse (CLCC) (UNICANCER)
Caen, France, 14076
Actively Recruiting
11
CHU de Dijon - Centre Georges-Francois-Leclerc (UNICANCER)
Dijon, France, 21079
Actively Recruiting
12
Centre Hospitalier Departemental Vendee (UNICANCER)
La Roche-sur-Yon, France, 85925
Actively Recruiting
13
Institut Paoli-Calmettes (UNICANCER)
Marseille, France, 13237
Not Yet Recruiting
14
Institut du Cancer de Montpellier (UNICANCER)
Montpellier, France, 34298
Actively Recruiting
15
Centre Catalan d'Oncologie (UNICANCER)
Perpignan, France, 66000
Actively Recruiting
16
CHU de Lyon - Hopital Lyon Sud (UNICANCER)
Pierre-Bénite, France, 69495
Actively Recruiting
17
Centre Henri Becquerel (UNICANCER)
Rouen, France, 76038
Actively Recruiting
18
Institut de Cancerologie Strasbourg Europe (UNICANCER)
Strasbourg, France, 67200
Actively Recruiting
19
Gustave Roussy (UNICANCER)
Villejuif, France, 94805
Actively Recruiting
20
Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH
Aachen, Germany, 52074
Not Yet Recruiting
21
IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST
Genova, Italy, 16132
Not Yet Recruiting
22
ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
Legnago, Italy, 37045
Not Yet Recruiting
23
Fondazione IRCCS - Policlinico San Matteo
Pavia, Italy, 27100
Not Yet Recruiting
24
ASST-Bergamo Ospedale Treviglio-Caravaggio
Treviglio, Italy, 24047
Not Yet Recruiting
25
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, Italy, 37134
Not Yet Recruiting
26
Medical University Of Gdansk
Gdansk, Poland, 80 211
Not Yet Recruiting
27
Regional Cancer Centre
Olsztyn, Poland, 10 228
Actively Recruiting
28
Hospital Universitario Badajoz
Badajoz, Spain, 06080
Not Yet Recruiting
29
Hospital Insular De Gran Canaria
Las Palmas de Gran Canaria, Spain, 35016
Not Yet Recruiting
30
Hospital Universitario Puerta De Hierro
Majadahonda, Spain, 28222
Actively Recruiting
31
Inselspital
Bern, Switzerland, 3010
Actively Recruiting
32
Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds
La Chaux-de-Fonds, Switzerland, 2303
Actively Recruiting
33
Kantonsspital St Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
34
UniversitaetsSpital Zurich
Zurich, Switzerland, 8091
Actively Recruiting
35
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
36
NHS Lothian - Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Not Yet Recruiting
37
Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital
Maidstone, United Kingdom, ME16 9QQ
Not Yet Recruiting
38
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
39
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
40
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Not Yet Recruiting
41
Royal Marsden Hospital - Sutton
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
E
EORTC Reception
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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