Etude : STEREO HBM /

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : STEREO HBM

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Radiothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 20/12/2021
CIM10 - Localisation(s)
Informations principales
Titre : Radiothérapie stéréotaxique pour les métastases cérébrales avec signal hémorragique récent : étude de phase 2 en 2 étapes

Spécialité : Toutes tumeurs solides
Localisation : C - Toutes localisations
Informations complémentaires
Schéma : This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases

-Experimental: FSRT Stereotactic radiation therapy
Each cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation

Phase : II

Stade : Métastatique

1, 2, 3, 4, X
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Age> 18 years
- Performance Status 0 or 1
- Patient with less than 4 brain metastases [of a solid tumor 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 :
-> hyperdense lesion on the non-injected CT (treatment scanner) and / or,
-> spontaneously hyperintense lesion on T1 MRI sequences without gadolinium injection and / or,
-> lesion with hypo signal on T2 sequences *
- Patient with controlled extra-cranial disease under systemic treatment (chemotherapy or targeted therapy):
-> illness in complete response
-> partial response or stable illness for more than 3 months
- Absence of meningeal tumor invasion
- Absence of brainstem metastasis
- DS-GPA of 3 or more
- Patient without concomitant anti-cancer therapy (chemotherapy, hormone therapy, immunotherapy, 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
- 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

Critères de non-inclusion : - Patient with small cell lung cancer, melanoma, germ cell tumors, lymphoma, leukemia and multiple myeloma
- Patient with a concomitant neurodegenerative disease
- Any symptoms not attributable to cerebral metastasis or cancerous pathology and requiring long-term use of corticosteroids (regardless of dose)
- Contraindication to brain MRI or gadolinium injection
- Hemorrhagic disorders other than intra-tumor bleeding from brain lesion (s)
- Radiosensitizing systemic disease (Neurofibromatosis ...)
- Thrombocytopenia less than 100,000 cells / mm3
- Anticoagulant treatment with curative dose, and / or anti-platelet aggregation during FSRT. If treatment can be delayed for at least 5 days before starting FSRT and resumed 2 months after completion of FSRT, the patient is eligible.
- Hemorrhagic metastasis (s) of the brainstem
- Planning of the treatment on the target metastasis delivering a dose> 5 Gy on other metastases concomitant
- Patient with prior cerebral stereotactic irradiation
- History of total brain irradiation
- Evolutionary extra-cranial disease
- Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study
- Participation in a therapeutic trial within 30 days
- Patient deprived of liberty or under guardianship
Informations relatives au promoteur
Promoteur :
Centre François BACLESSE
Type de sponsor : Institutionnel
14000 CAEN

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt :

Investigateur :

Sophie DANET

Statut de l'essai : OUVERT

MAJ : 07/08/2019