Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal

Summary

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

Conditions2

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