Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps

Centre Francois Baclesse4 sites in 1 country46 target enrollmentJanuary 16, 2019

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hemorrhagic Brain Metastases
Sponsor: Centre Francois Baclesse
Enrollment: 46
Locations: 4
Primary Endpoint: Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)
Status: Recruiting
Last Updated: last year

This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases

Registry

clinicaltrials.gov

Start Date

January 16, 2019

End Date

January 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Centre Francois Baclesse

Responsible Party

Sponsor

•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 :
•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 \*
•Absence of meningeal tumor invasion

•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
•Hemorrhagic disorders other than intra-tumor bleeding from brain lesion (s)
•Radiosensitizing systemic disease (Neurofibromatosis ...)
•Thrombocytopenia less than 100,000 cells / mm3
•Anticoagulant treatment, and / or anti-platelet aggregation with curative et prophylaxic dose during FSRT. If treatment can be delayed for at least 5 days before starting FSRT and resumed 2 weeks 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