PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
NCT ID: NCT04790253
Last Updated: 2023-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
600 participants
INTERVENTIONAL
2022-10-27
2028-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy
NCT04829708
Prophylactic Cranial Irradiation (PCI) Cognitive Tests in Non-small Cell Lung Cancer (NSCLC) Patients
NCT01290809
Watchful Observation of Patients With LD-SCLC Instead of the PCI
NCT04168281
PCI for Patients With ES-SCLC After RCT:a Prospective Randomized Study
NCT04535739
A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain
NCT05419076
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PCI followed by brain MR surveillance
Prophylactic cranial irradiation will be delivered at the dose of 25 Gy in 10 fractions to the whole brain.
Patients must have a brain MRI performed within 28 days before randomisation and at 3, 6, 9, 12, 18 and 24 months.
Extracranial imaging is recommended and will be performed per institutional standards at the discretion of the treating physician.
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.
MRI Active Surveillance
Patients must have a brain MRI performed within 28 days before randomisation and at 3, 6, 9, 12, 18 and 24 month. Clinical evaluation will be performed every 3 months.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically/cytologically proven diagnosis of SCLC
* Limited and extensive stage
* LS SCLC: Stage I-III (T any, N any, M0, according to UICC TNM staging v8.0) that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a tolerable radiation plan.
* ES SCLC: Stage IV (T any, N any, M 1a/b), or T3-4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a tolerable radiation plan.
* Completed standard therapy prior to randomization:
* For patients with LS-SCLC, this includes a combination of 4-6 cycles of platinum-based doublet chemotherapy and either definitive thoracic radiotherapy (including SBRT for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician, but is not mandated.
* For patients with ES-SCLC, this includes 4-6 cycles of platinum-based doublet chemotherapy either with or without thoracic radiotherapy
o Immunotherapy concurrent with and/or adjuvant to standard therapy is allowed at the discretion of the treating physician.
* Absence of progressive disease after completed standard therapy on systemic imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of Chest/Abdomen/Pelvis and brain MRI), 28 days before randomization.
* Absence of brain metastases or leptomeningeal disease after completed standard therapy on systemic imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of Chest/Abdomen/Pelvis and brain MRI), within 28 days before randomization.
* Interval from day 1 of last cycle of chemotherapy to randomization of ≤8 weeks
* ECOG PS ≤ 2
* Estimated creatinine clearance ≥ 30 mL/min as calculated using the MDRD formula
* Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization.
Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression or other reasons.
* Patients Women of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the entire period of the radiotherapy treatment study participation and for at least 30 days after the last dose of radiotherapy. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
* Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
* Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
* Intrauterine device (IUD)
* Intrauterine hormone-releasing system (IUS)
* Bilateral tubal occlusion
* Vasectomized partner
* Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
* Female subjects who are breast feeding should discontinue nursing prior to the first dose of radiotherapy and during the entire period of the radiotherapy treatmentuntil 30 days after the administration of the last dose of radiotherapy.
* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
* Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion Criteria
* Known contraindication to imaging tracer or any product of contrast media, such as allergy or insufficient renal function. Known contraindication to MRI, such as implanted metal devices or foreign bodies.
* Other active hematologic or solid tumour malignancy requiring current active treatment.
* Any unresolved toxicities from prior therapy (e.g., chemotherapy, radiotherapy) greater than CTCAE grade 2 (according to CTCAE v5.0) at the time of randomization.
* Patient with severe active comorbidities, defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to randomization
* Transmural myocardial infarction within 6 months prior to randomization
* Acute infection requiring treatment at the time of randomization
* Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization
* Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease
* HIV positive with CD4 count \< 200 cells/microliter. Note: patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 16 weeks prior to randomization.
* Any severe comorbidity that in the opinion of the Investigator might hamper the participation to the study and/or the treatment administration.
* Severe neurological (including dementia and epilepsy) or psychiatric disorder requiring active treatment.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UNICANCER
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Corinne Faivre-Finn, MD
Role: PRINCIPAL_INVESTIGATOR
The Christie NHS Foundation Trust
Antonin Levy, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Gustave Roussy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Institut DC de Montpellier
Role: primary
CHU Lyon DLHL Lyon Sud
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EORTC-1901-LCG
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.