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| ID | Type | Description | Link |
|---|---|---|---|
| 20.06.16-36701 | Other Identifier | Ethics committee Sud-Ouest et Outre-Mer IV |
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| Name | Class |
|---|---|
| Groupement Interrégional de Recherche Clinique et d'Innovation | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm (all patients) | Experimental | Patients will receive preoperative hypofractionated stereotactic radiosurgery (SRS). According to the association of french-speaking neuro-oncologists (ANOCEF) recommendations, total dose and fractionation will be 33 Gy in 3 fractions at the isocenter, 23.1 Gy in envelope (70% isodose), i.e. 30 Gy in growth tumor volume (GTV) envelope.) Surgery will take place within 3 days of the preoperative SRS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative SRS | Procedure | Patient will be treat with preoperative SRS and then surgery for brain metastases is realized within 3 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after preoperative SRS (M6) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after preoperative SRS (M12) |
| Evaluation of 1-year radionecrosis rate after preoperative SRS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucie BRUN, MD | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean PERRIN | Clermont-Ferrand | Puy-de-Dôme | 63800 | France | ||
| CHU Grenoble Alpes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34320940 | Result | Ginzac A, Dupic G, Brun L, Molnar I, Casile M, Durando X, Verrelle P, Lemaire JJ, Khalil T, Biau J. Preoperative stereotactic radiosurgery for brain metastases: the STEP study protocol for a multicentre, prospective, phase-II trial. BMC Cancer. 2021 Jul 28;21(1):864. doi: 10.1186/s12885-021-08602-0. |
| Label | URL |
|---|---|
| Study protocol article | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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) |
| 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. | 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". | 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 | 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 | 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 | 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) | 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) | At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12) |
| Grenoble |
| 38700 |
| France |
| Hospices Civils de Lyon | Lyon | 69002 | France |
| Centre Léon BÉRARD | Lyon | 69373 | France |
| Centre Hospitalier d'Annecy-Genevois | Metz-Tessy | 74370 | France |
| Institut de Cancérologie de l'Ouest | Saint-Herblain | France |
| Institut de cancérologie de la Loire Lucien Neuwirth | Saint-Priest-en-Jarez | 42270 | France |
| Institut de cancérologie Strasbourg Europe (ICANS) | Strasbourg | 67000 | France |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |