GEOQ

TITRE	(EN) A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases
PROTOCOLE ID	NRG-BN012
CLINICAL TRIAL.gov ID	NCT05438212
TYPE(S) DE CANCER	Cerveau (SNC)
PHASE	Phase III
TYPE D'ÉTUDE	Clinique
INSTITUTION	CUSM 1001 boul. Décarie
VILLE	Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E)	Christina Tsien
COORDONATEUR(RICE)	Tatiana Carvalho tatiana.carvalho@muhc.mcgill.ca 514-934-1934 poste 43698
STATUT	Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ	(EN) Radiographic confirmation of 1-4 brain metastases, one of which requires resection, as defined by magnetic resonance imaging (MRI) with contrast obtained within 14 days prior to registration The maximum diameter of the lesion to be resected on the post-contrast MRI, as measured on any orthogonal plane (axial, sagittal, coronal), must measure > 2.0 cm and < 5.0 cm. The maximum diameter of the lesions not to be resected must measure < 4.0 cm Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years All brain metastases must be located > 5 mm from the optic chiasm and outside the brainstem Patient is able to medically tolerate surgery and SRS The lesion chosen for surgical therapy must be deemed an appropriate target for safe, gross total resection by the treating surgeon History/physical examination within 14 days prior to registration Age >= 18 Karnofsky performance status (KPS) >= 60 within 14 days prior to registration A negative urine or serum pregnancy test (in persons of childbearing potential) within =< 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal for at least 12 consecutive months Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
CRITÈRES D'EXCLUSION	(EN) Prior cranial radiotherapy, including whole brain radiotherapy, or SRS to the resection site Note: The index lesion to be resected cannot have been previously treated with SRS (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol). Previous SRS to other lesions is allowed Evidence of leptomeningeal disease (LMD) Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion Any medical conditions which would make this protocol unreasonably hazardous, including, but not limited to: contraindications to general endotracheal anesthesia; intracranial surgery; and stereotactic radiosurgery Primary histology of germ cell tumor, small cell carcinoma or lymphoma More than one brain metastasis planned for resection Inability to undergo MRI with contrast Planned administration of cytotoxic chemotherapy or tyrosine/multi-kinase inhibitors within the 3 days prior to, the day of, or within 3 days after the completion of SRS Note: chemotherapy and immunotherapy outside of this window are allowed

Cerveau (SNC)