Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal
ConditionHemorrhagic Brain Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Francois Baclesse
About this trial
This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient with small cell lung cancer, 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
Trial design
Design model
Single group
Treatments tested in this trial
FSRT Stereotactic radiation therapy
RadiationFor each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: FSRT Stereotactic radiation therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)
Time frame
6 months after end of Stereotactic radiation therapy2
Local tumoral response rate defined according to the recommendations of the RECIST criteria
Time frame
6 months after end of Stereotactic radiation therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Francois Baclesse
Lead sponsor
ANOCEF/IGCNO
Collaborator
Groupement Interrégional de Recherche Clinique et d'Innovation
Collaborator
Source ClinicalTrials.gov