Informations générales (source: ClinicalTrials.gov)
PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
Interventional
N/A
European Organisation for Research and Treatment of Cancer - EORTC (Voir sur ClinicalTrials)
octobre 2022
avril 2028
12 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antonin LEVY | 18/03/2024 11:06:17 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Catalan d'Oncologie (UNICANCER) - 66000 - Perpignan - France | Contact (sur clinicalTrials) | ||||
| Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER) - 64100 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Centre Francois Baclesse (CLCC) (UNICANCER) - 14076 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Henri Becquerel (UNICANCER) - 76038 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Departemental Vendee (UNICANCER) - 85925 - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| CHU de Dijon - Centre Georges-Francois-Leclerc (UNICANCER) - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| CHU de Lyon - Hopital Lyon Sud (UNICANCER) - 69495 - Pierre Benite Cedex - France | CHU Lyon DLHL Lyon Sud | Contact (sur clinicalTrials) | |||
| Institut Bergonie (UNICANCER) - 33067 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie Strasbourg Europe (UNICANCER) - 67200 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut du Cancer de Montpellier (UNICANCER) - 34298 - Montpellier - France | Institut DC de Montpellier | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes (UNICANCER) - 13237 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine (UNICANCER) - 84918 - Avignon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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