🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity ◆ Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing ◆ Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich ◆ Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery ◆ Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma ◆ Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide ◆ The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany ◆ Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact ◆ Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity ◆ Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing ◆ Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich ◆ Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery ◆ Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma ◆ Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide ◆ The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany ◆ Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact ◆
Clinical Trials in Poland / NCT04790253
Recruiting Not applicable

PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

NCT04790253 · tracked via the Priya Life Science Poland tracker
Phase
Not applicable
Started
2022-10-27
Last updated
2023-11-03

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Prophylactic cranial irradiation

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * 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: * Prior radiotherapy to the brain or whole brain radiotherapy. Note: Patients who have undergone prior stereotactic radiosurgery for benign tumours or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis. Discussion with EORTC Headquarters is mandatory, before the randomization. * 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

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Medical University of Graz - Radio-oncology Graz Austria Recruiting
Institut Jules Bordet Anderlecht Belgium Recruiting
Universitair Ziekenhuis Antwerpen Edegem Belgium Recruiting
AZ Groeninge Kortrijk - Campus Kennedylaan Kortrijk Belgium Recruiting
C.H.U. Sart-Tilman Liège Belgium Recruiting
Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus Wilrijk Belgium Recruiting
Institut Sainte Catherine (UNICANCER) Avignon France Recruiting
Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER) Bayonne France Recruiting
Institut Bergonie (UNICANCER) Bordeaux France Recruiting
Centre Francois Baclesse (CLCC) (UNICANCER) Caen France Recruiting
CHU de Dijon - Centre Georges-Francois-Leclerc (UNICANCER) Dijon France Recruiting
Centre Hospitalier Departemental Vendee (UNICANCER) La Roche-sur-Yon France Recruiting
Institut Paoli-Calmettes (UNICANCER) Marseille France Not Yet Recruiting
Institut du Cancer de Montpellier (UNICANCER) Montpellier France Recruiting
Centre Catalan d'Oncologie (UNICANCER) Perpignan France Recruiting
CHU de Lyon - Hopital Lyon Sud (UNICANCER) Pierre-Bénite France Recruiting
Centre Henri Becquerel (UNICANCER) Rouen France Recruiting
Institut de Cancerologie Strasbourg Europe (UNICANCER) Strasbourg France Recruiting
Gustave Roussy (UNICANCER) Villejuif France Recruiting
Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH Aachen Germany Not Yet Recruiting
IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST Genova Italy Not Yet Recruiting
ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital Legnago Italy Not Yet Recruiting
Fondazione IRCCS - Policlinico San Matteo Pavia Italy Not Yet Recruiting
ASST-Bergamo Ospedale Treviglio-Caravaggio Treviglio Italy Not Yet Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma Verona Italy Not Yet Recruiting
Medical University Of Gdansk Gdansk Poland Not Yet Recruiting
Regional Cancer Centre Olsztyn Poland Recruiting
Hospital Universitario Badajoz Badajoz Spain Not Yet Recruiting
Hospital Insular De Gran Canaria Las Palmas de Gran Canaria Spain Not Yet Recruiting
Hospital Universitario Puerta De Hierro Majadahonda Spain Recruiting
Inselspital Bern Switzerland Recruiting
Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds La Chaux-de-Fonds Switzerland Recruiting
Kantonsspital St Gallen Sankt Gallen Switzerland Recruiting
UniversitaetsSpital Zurich Zurich Switzerland Recruiting
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre Bristol United Kingdom Recruiting
NHS Lothian - Western General Hospital Edinburgh United Kingdom Not Yet Recruiting
Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital Maidstone United Kingdom Not Yet Recruiting
The Christie NHS Foundation Trust Manchester United Kingdom Recruiting
Nottingham University Hospitals NHS Trust - City Hospital Nottingham United Kingdom Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital Sheffield United Kingdom Not Yet Recruiting

+ 1 more sites — see the full list on the official registry below.

More European Organisation for Research and Treatment of Cancer - EORTC trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04790253 on ClinicalTrials.gov ↗ ← All trials in Poland