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

Who is this study for? Patients with small-cell lung cancer
What treatments are being studied? Prophylactic cranial irradiation
Status: Recruiting
Location: See all (41) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Austria
Medical University of Graz - Radio-oncology
RECRUITING
Graz
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
Universitair Ziekenhuis Antwerpen
RECRUITING
Edegem
AZ Groeninge Kortrijk - Campus Kennedylaan
RECRUITING
Kortrijk
C.H.U. Sart-Tilman
RECRUITING
Liège
Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus
RECRUITING
Wilrijk
France
Institut Sainte Catherine (UNICANCER)
RECRUITING
Avignon
Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER)
RECRUITING
Bayonne
Institut Bergonie (UNICANCER)
RECRUITING
Bordeaux
Centre Francois Baclesse (CLCC) (UNICANCER)
RECRUITING
Caen
CHU de Dijon - Centre Georges-Francois-Leclerc (UNICANCER)
RECRUITING
Dijon
Centre Hospitalier Departemental Vendee (UNICANCER)
RECRUITING
La Roche-sur-yon
Institut Paoli-Calmettes (UNICANCER)
NOT_YET_RECRUITING
Marseille
Institut du Cancer de Montpellier (UNICANCER)
RECRUITING
Montpellier
Centre Catalan d'Oncologie (UNICANCER)
RECRUITING
Perpignan
CHU de Lyon - Hopital Lyon Sud (UNICANCER)
RECRUITING
Pierre-bénite
Centre Henri Becquerel (UNICANCER)
RECRUITING
Rouen
Institut de Cancerologie Strasbourg Europe (UNICANCER)
RECRUITING
Strasbourg
Gustave Roussy (UNICANCER)
RECRUITING
Villejuif
Germany
Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH
NOT_YET_RECRUITING
Aachen
Italy
IRCCS Azienda Ospedaliera Universitaria San Martino IST - IRCCS - AUO San Martino - IST
NOT_YET_RECRUITING
Genova
ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
NOT_YET_RECRUITING
Legnago
Fondazione IRCCS - Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
ASST-Bergamo Ospedale Treviglio-Caravaggio
NOT_YET_RECRUITING
Treviglio
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
NOT_YET_RECRUITING
Verona
Poland
Medical University Of Gdansk
NOT_YET_RECRUITING
Gdansk
Regional Cancer Centre
RECRUITING
Olsztyn
Spain
Hospital Universitario Badajoz
NOT_YET_RECRUITING
Badajoz
Hospital Insular De Gran Canaria
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Puerta De Hierro
RECRUITING
Majadahonda
Switzerland
Inselspital
RECRUITING
Bern
Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds
RECRUITING
La Chaux-de-fonds
Kantonsspital St Gallen
RECRUITING
Sankt Gallen
UniversitaetsSpital Zurich
RECRUITING
Zurich
United Kingdom
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
RECRUITING
Bristol
NHS Lothian - Western General Hospital
NOT_YET_RECRUITING
Edinburgh
Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital
NOT_YET_RECRUITING
Maidstone
The Christie NHS Foundation Trust
RECRUITING
Manchester
Nottingham University Hospitals NHS Trust - City Hospital
RECRUITING
Nottingham
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
NOT_YET_RECRUITING
Sheffield
Royal Marsden Hospital - Sutton
RECRUITING
Sutton
Contact Information
Primary
EORTC Reception
eortc@eortc.org
+3227741611
Time Frame
Start Date: 2022-10-27
Estimated Completion Date: 2028-04
Participants
Target number of participants: 600
Treatments
Active_comparator: 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.
No_intervention: 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.
Sponsors
Leads: European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: UNICANCER

This content was sourced from clinicaltrials.gov

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