Evolution of Hypofractionated Stereotactic Irradiation for Radio-Resistant Brain Metastases From D1-3-5 to D1-2-3

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Paul Strauss

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • D1-3-5 radiotherapy
  • D1-2-3 radiotherapy

Treatment groups

264 Participants
are divided into 2 treatment groups

Sponsors and collaborators