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| Name | Class |
|---|---|
| ANOCEF/IGCNO | UNKNOWN |
| Groupement Interrégional de Recherche Clinique et d'Innovation | OTHER |
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This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FSRT Stereotactic radiation therapy | Experimental | Each cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FSRT Stereotactic radiation therapy | Radiation | For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage) | 6 months after end of Stereotactic radiation therapy | |
| Local tumoral response rate defined according to the recommendations of the RECIST criteria | 6 months after end of Stereotactic radiation therapy |
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Inclusion Criteria:
Age> 18 years
Performance Status 0 or 1
Patient with less than 4 brain metastases [of a solid tumor, including melanoma, with a histologically proven diagnosis for the solid tumor; Patients who have had a metastasectomy and 1 to 3 brain metastatic lesions are eligible.
Brain injury (s) measuring between 5 and 30 mm in diameter
Patient eligible for stereotactic radiotherapy after a decision of the multidisciplinary committee
Presence of intra-tumor bleeding signals on at least one brain injury before stereotactic irradiation and defined by :
Absence of meningeal tumor invasion
Absence of brainstem metastasis
DS-GPA depending on the histological type (https://brainmetgpa.com/#start):
Patient without concomitant anti-cancer therapy (chemotherapy, hormone therapy, anti-angiogenic or other anti-cancer treatments). Treatments should be suspended for at least 7 days before the start of FSRT radiotherapy. The treatment can be resumed 7 days after the end of radiotherapy. It's not mandatory to suspend immunotherapy
Life expectancy estimated at over 6 months
Patient cooperating sufficiently to perform the treatment with the use of a thermoformed mask
Patient whose neuropsychological capacities make it possible to follow the requirements of the protocol
Patient affiliated to a social security scheme
Patient giving written consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien GEFRELOT, MD | Contact | 0231455020 | j.geffrelot@baclesse.unicancer.fr | |
| Dinu STEFAN, MD | Contact | 0231455020 | d.stefan@baclesse.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de la Baie | Recruiting | Avranches | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32087691 | Derived | Lesueur P, Kao W, Leconte A, Geffrelot J, Lequesne J, Lacroix J, Brachet PE, Hrab I, Royer P, Clarisse B, Stefan D. Stereotactic radiotherapy on brain metastases with recent hemorrhagic signal: STEREO-HBM, a two-step phase 2 trial. BMC Cancer. 2020 Feb 22;20(1):147. doi: 10.1186/s12885-020-6569-1. |
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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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| Centre François Baclesse | Recruiting | Caen | France |
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| Hospices Civils de Lyon | Recruiting | Lyon | France |
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| Institut de Cancérologie de Lorraine | Recruiting | Nancy | France |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |