STEP is a French multicentre, prospective, non-randomized, phase II study designed to assess 6-months local control after pre-operative stereotactic radiosurgery (SRS) for patients with brain metastases
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Patient will be treat with preoperative SRS and then surgery for brain metastases is realized within 3 days.
Centre Jean PERRIN
Clermont-Ferrand, Puy-de-Dôme, France
CHU Grenoble Alpes
Grenoble, France
Hospices Civils de Lyon
Lyon, France
Centre Léon BÉRARD
Lyon, France
Evaluation of 6-months local control rate after preoperative SRS
Local recurrence is defined as the onset or progression of nodular contrast grafting within the resection cavity according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.
Time frame: 6 months after preoperative SRS (M6)
Evaluation of 1-year local control rate after preoperative SRS
Local recurrence is defined as the onset or progression of nodular contrast grafting within the resection cavity according to the RANO-BM criteria.
Time frame: 12 months after preoperative SRS (M12)
Evaluation of 1-year radionecrosis rate after preoperative SRS
Radionecrosis is defined either histologically post-operatively according to the anatomopathological report or in the absence of salvage surgery by the appearance or increase of gadolinium contrast on T1 MRI sequences associated with an increase in the cerebral brain volume (CBV) ratio (brain blood volume of the tumour / brain blood volume of the non-tumour white matter) of less than 2 on perfusion MRI sequences and/or a standard uptake volume (SUV max) of less than 1, 59 on positron emission tomography (PET) scanners at 6-fluoro-\[18 fluoro\]-L-dihydroxyphenylalanine (F-DOPA)
Time frame: 12 months after preoperative SRS (M12)
Evaluation of overall survival
defined as the time interval between the date of preoperative radiosurgery and the date of death from any cause.
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Evaluation of acute (less than 3 months post preoperative SRS) and delayed toxicities (more than 3 months after preoperative SRS)
They will be collected and graded according to the NCI-CTCAE v5.0 scale. An adverse event of grade ≥ 3 will be considered "severe".
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Centre Hospitalier d'Annecy-Genevois
Metz-Tessy, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Institut de cancérologie de la Loire Lucien Neuwirth
Saint-Priest-en-Jarez, France
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, France
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Rate of leptomeningeal relapses
According to cerebral MRI
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Evaluation of cerebral distant control
Follow by MRI
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Determination of predictive factors for local brain control, complication and prognosis factors for survival
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Evaluation of cognitive function
Mini-mental state examination (MMSE)
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Evaluation of quality of life
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30)
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)