Recruiting NCT03696680

Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal

Phase II Interventional Hemorrhagic Brain Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: FSRT Stereotactic radiation therapy.
Who it may be relevant to: Registry conditions: Hemorrhagic Brain Metastases. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

Radiation FSRT Stereotactic radiation therapy
For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days

Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage) [Time frame: 6 months after end of Stereotactic radiation therapy]
Local tumoral response rate defined according to the recommendations of the RECIST criteria [Time frame: 6 months after end of Stereotactic radiation therapy]

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

France · 4 centers

Lesueur P, Kao W, Leconte A, Geffrelot J, Lequesne J, Lacroix J, Brachet PE, Hrab I, Royer P, Clarisse B, Stefan D. Stereotactic radiotherapy on brain metastases with recent hemorrhagic signal: STEREO-HBM, a two-step phase 2 trial. BMC Cancer. 2020 Feb 22;20(1):147. doi: 10.1186/s12885-020-6569-1. PMID 32087691

NCT: NCT03696680 · 2018-A00926-49