Overview

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

Eligibility

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 :
  • 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
• Absence of brainstem metastasis
• DS-GPA depending on the histological type (https://brainmetgpa.com/#start):
  • Lung Adecarcinoma: DS-GPA 2 or +
  • Non-adenocarcinoma lung: DS-GPA 2.5 or +
  • Kidney: DS-GPA 2.5 or +
  • Breast: DS-GPA 2.5 or +
  • Digestive cancer: DS-GPA 3 or +
  • Melanoma: DS-GPA 1.5 or +
• 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:

• 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
• Patient with prior cerebral stereotactic irradiation
• History of total brain irradiation
• Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study
• Participation in a therapeutic trial that could compromise the conduct of study
• Patient deprived of liberty or under guardianship