A randomized, unblinded, multicenter, two-arm registration study of SonoCloud-9 combined with Carboplatin (CBDCA) compared to standard Lomustine (CCNU) or Temozolomide (TMZ) in patients undergoing planned resection for a first recurrent glioblastoma - SONOBIRD

Criteri di partecipazione
1. Histologically proven glioblastoma (WHO CRITERIA 2021), absence of an IDH mutation proven by negative IDH1-R132H staining in the context of an IHC procedure. 2. The patient must have previously received a first-line therapy that must have included the following two components: a) Surgery or biopsy and a standard fractionated radiotherapy (1.8 to 2 Gy/fraction, > 56 Gy, < 66 Gy) or a hypofractionated radiotherapy (15 x 2.66 Gy or similar regimen) b) A maintenance chemotherapy line and/or an immunotherapy or biologic therapy (with or without TTFields) 3. There must have been a first unequivocal disease progression, with a) measurable tumor (>100 mm2 or 1 cm3, according to RANO criteria), documented (e.g., increase in tumor diameter by 25%) on MRI performed within 14 days prior to study enrollment, and b) the last radiotherapy must have been completed at least 12 weeks prior, unless there is a new lesion outside the radiation field or clear evidence of a viable tumor in the form of a histopathological sample. (BASEC)

Criteri di esclusione
1. T1-weighting shows multifocal enhanced tumor areas (unless all are located within a 5 cm diameter area) 2. Tumor of the posterior cranial fossa 3. The patient has a known BRAF/NTKR mutation (BASEC)