search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Prophylactic cranial irradiation
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Limited Stage Small Cell Lung Cancer focused on measuring Prophylactic cerebral Irradiation, small cell lung cancer, PCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Graz - Radio-oncologyRecruiting
  • Institut Jules BordetRecruiting
  • Universitair Ziekenhuis AntwerpenRecruiting
  • AZ Groeninge Kortrijk - Campus KennedylaanRecruiting
  • C.H.U. Sart-TilmanRecruiting
  • Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-AugustinusRecruiting
  • Institut Sainte Catherine (UNICANCER)Recruiting
  • Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER)Recruiting
  • Institut Bergonie (UNICANCER)
  • Centre Francois Baclesse (CLCC) (UNICANCER)Recruiting
  • CHU de Dijon - Centre Georges-Francois-Leclerc (UNICANCER)Recruiting
  • Centre Hospitalier Departemental Vendee (UNICANCER)Recruiting
  • Institut Paoli-Calmettes (UNICANCER)
  • Institut du Cancer de Montpellier (UNICANCER)Recruiting
  • Centre Catalan d'Oncologie (UNICANCER)Recruiting
  • CHU de Lyon - Hopital Lyon Sud (UNICANCER)Recruiting
  • Centre Henri Becquerel (UNICANCER)Recruiting
  • Institut de Cancerologie Strasbourg Europe (UNICANCER)Recruiting
  • Gustave Roussy (UNICANCER)Recruiting
  • Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH
  • IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST
  • ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
  • Fondazione IRCCS - Policlinico San Matteo
  • ASST-Bergamo Ospedale Treviglio-Caravaggio
  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
  • Medical University Of Gdansk
  • Regional Cancer CentreRecruiting
  • Hospital Universitario Badajoz
  • Hospital Insular De Gran Canaria
  • Hospital Universitario Puerta De Hierro
  • InselspitalRecruiting
  • Reseau Hospitalier Neuchatelois - RHNe - La Chaux de FondsRecruiting
  • Kantonsspital St GallenRecruiting
  • UniversitaetsSpital ZurichRecruiting
  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology CentreRecruiting
  • NHS Lothian - Western General Hospital
  • Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital
  • The Christie NHS Foundation TrustRecruiting
  • Nottingham University Hospitals NHS Trust - City HospitalRecruiting
  • Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
  • Royal Marsden Hospital - SuttonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

PCI followed by brain MR surveillance

MRI Active Surveillance

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall survival
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

Secondary Outcome Measures

cognitive failure free survival
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)
Quality of Life
To show that 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
Safety profiling
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).

Full Information

First Posted
March 5, 2021
Last Updated
August 31, 2023
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
UNICANCER
search

1. Study Identification

Unique Protocol Identification Number
NCT04790253
Brief Title
PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
Acronym
PRIMALung
Official Title
PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
April 2028 (Anticipated)
Study Completion Date
April 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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 under the treatment policy strategy. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limited Stage Small Cell Lung Cancer, Extensive-stage Small-cell Lung Cancer
Keywords
Prophylactic cerebral Irradiation, small cell lung cancer, PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After eligibility checks, patients will be randomized between the 2 arms, and stratified by stage of disease (limited versus extensive), immunotherapy as part of the first-line treatment (yes/no), and ECOG Performance Status (0 or 1 versus 2).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCI followed by brain MR surveillance
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MRI Active Surveillance
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Prophylactic cranial irradiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Description
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
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
cognitive failure free survival
Description
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)
Time Frame
12 Months
Title
Quality of Life
Description
To show that 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
Time Frame
12 Months
Title
Safety profiling
Description
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).
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EORTC Reception
Phone
+3227741611
Email
eortc@eortc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Faivre-Finn, MD
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonin Levy, MD
Organizational Affiliation
Centre Gustave Roussy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz - Radio-oncology
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanja Langsenlehner, MD
Facility Name
Institut Jules Bordet
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Berghmans, MD
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelies Janssens, MD
Facility Name
AZ Groeninge Kortrijk - Campus Kennedylaan
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie Derycke, MD
Facility Name
C.H.U. Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Freres, MD
Facility Name
Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Billiet, MD
Facility Name
Institut Sainte Catherine (UNICANCER)
City
Avignon
ZIP/Postal Code
84918
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pourel Nicolas, MD
Facility Name
Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER)
City
Bayonne
ZIP/Postal Code
64100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurelien Blouet, MD
Facility Name
Institut Bergonie (UNICANCER)
City
Bordeaux
ZIP/Postal Code
33067
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Batard, MD
Facility Name
Centre Francois Baclesse (CLCC) (UNICANCER)
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine Lerouge, MD
Facility Name
CHU de Dijon - Centre Georges-Francois-Leclerc (UNICANCER)
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne Martin, MD
Facility Name
Centre Hospitalier Departemental Vendee (UNICANCER)
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clotilde Morand, MD
Facility Name
Institut Paoli-Calmettes (UNICANCER)
City
Marseille
ZIP/Postal Code
13237
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonel Varela Cagetti, MD
Facility Name
Institut du Cancer de Montpellier (UNICANCER)
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Institut DC de Montpellier
First Name & Middle Initial & Last Name & Degree
Pierre Boisselier, MD
Facility Name
Centre Catalan d'Oncologie (UNICANCER)
City
Perpignan
ZIP/Postal Code
66000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Vieillot, MD
Facility Name
CHU de Lyon - Hopital Lyon Sud (UNICANCER)
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHU Lyon DLHL Lyon Sud
First Name & Middle Initial & Last Name & Degree
Marielle Le Bon, MD
Facility Name
Centre Henri Becquerel (UNICANCER)
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thureau Sebastien, MD
Facility Name
Institut de Cancerologie Strasbourg Europe (UNICANCER)
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine Antoni, MD
Facility Name
Gustave Roussy (UNICANCER)
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonin Levy, MD
Facility Name
Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Eble, MD
Facility Name
IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Genova, MD
Facility Name
ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
City
Legnago
ZIP/Postal Code
37045
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Bonetti, MD
Facility Name
Fondazione IRCCS - Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea R Filippi, MD
Facility Name
ASST-Bergamo Ospedale Treviglio-Caravaggio
City
Treviglio
ZIP/Postal Code
24047
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Luciani, MD
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Menis, MD
Facility Name
Medical University Of Gdansk
City
Gdańsk
ZIP/Postal Code
80 211
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krzysztof Konopa, MD
Facility Name
Regional Cancer Centre
City
Olsztyn
ZIP/Postal Code
10 228
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergiusz Nawrocki, MD
Facility Name
Hospital Universitario Badajoz
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquin Cabrera Rodriguez, MD
Facility Name
Hospital Insular De Gran Canaria
City
Las Palmas De Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Estival, MD
Facility Name
Hospital Universitario Puerta De Hierro
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Lopez Valcarcel, MD
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olgun Elicin, MD
Facility Name
Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds
City
La Chaux-de-Fonds
ZIP/Postal Code
2303
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olalla Santa Cruz, MD
Facility Name
Kantonsspital St Gallen
City
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul M Putora, MD
Facility Name
UniversitaetsSpital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolaus Andratschke, MD
Facility Name
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gareth Ayre, MD
Facility Name
NHS Lothian - Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsty MacLennan, MD
Facility Name
Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Sevitt, MD
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corinne Faivre-Finn, MD
Facility Name
Nottingham University Hospitals NHS Trust - City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerstie Johnson, MD
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Hatton, MD
Facility Name
Royal Marsden Hospital - Sutton
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona McDonald, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs