The goal of this prospective, multi-center, randomized double-arm clinical trial is to demonstrate a benefit in term of local control of a shorter spread of hypofractionated stereotactic radiotherapy at D1-2-3 vs D1-3-5, in the treatment of "radioresistant" Brain Metastases (BM). This trial aims to recruit patients with 1 to 5 unoperated BM originating from radioresistant primary sites. Patients will be randomly assigned to either the D1-3-5 radiotherapy arm or the D1-2-3 radiotherapy arm. Stereotactic brain irradiation will be administered at a dose of 33 Gy delivered in 3 fractions.
Age > 18 years
Patients with one or more unoperated brain metastases (1-5) originating from radioresistant primary locations, including melanoma, kidney, digestive, sarcoma, and prostate *
Karnofsky Performance Status (KPS) greater than 50% (Annex 3).
Absence of major psychiatric conditions in the medical history that may interfere with follow-up, based on the investigator's judgement.
Pregnant or breastfeeding women
An unoperated brain metastasis whose maximum diameter is > 3.5 cm
Patients deprived of liberty or under guardianship (including curatorship).
Patients with a history of cerebral radiotherapy.
Parallel
D1-3-5 radiotherapy
Radiation23.1 Gray (Gy) delivered in 3 fractions of 7.7 Gy at D1, D3, and D5
D1-2-3 radiotherapy
Radiation23.1 Gray (Gy) delivered in 3 fractions of 7.7 Gy at D1, D2, and D3
Local control of brain metastases at 6 months
Local control at 6 months per brain metastasis evaluated with magnetic resonance imaging (MRI)
Local control of brain metastases at 12, 18 and 24 months
Local control at 6 months per brain metastasis evaluated with magnetic resonance imaging (MRI).
Cerebral control at 12, 18 and 24 months
Cerebral control is defined as the assessment of the control of the entire cerebral parenchyma, including the treated site(s) evaluated with magnetic resonance imaging (MRI).
Overall survival
The time from the date of randomization to the date of death, whatever the cause. Patients alive at the time of analysis will be censored on the date of last contact.
Progression-free survival
Time between the date of randomization and the date of first progression of the irradiated site (or one of the sites irradiated in the event of irradiation of several sites) or the date of death. Patients alive without progression will be censored on the last news date.
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