About this trial
High-risk meningiomas always require postsurgical radiation treatment. Recent evidence has shown that increased radiation therapy dose may be associated with increased intracranial control of disease. In order to better define the volume of radiation treatment, the addition of PET imaging with somatostatin receptor tracers adds additional information compared to encephalon MRI with MoC alone.The present study aims to investigate whether radiation treatment with higher doses than the standard and defined using PET imaging can be safe and at the same time effective in order to increase progression-free survival in high-risk meningiomas.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 16 years;
Ability to express appropriate informed consent to treatment;
Diagnosis of grade III meningioma (regardless of presence of residual) or diagnosis of recurrence of grade II meningioma (regardless of presence of residual) or first diagnosis of grade II meningioma with presence of residual;
In case of recurrence, confirmation can be either histological or radiological;
Disqualifiers
Refusal to radiation treatment (i.e., absence of signed informed consent);
Other concomitant oncologic therapies
Current pregnancy;
Grade I meningiomas or Grade II meningiomas if operated on at first diagnosis with radical resection;
Trial design
Single group
Treatments tested in this trial
Dose escalation of radiation therapy, based on somatostatin receptor PET imaging
RadiationRadiation treatment with higher doses than the standard and defined using PET imaging
Treatment groups
Trial outcomes
Primary outcomes
Incidence of brain radionecrosis
Incidence of symptomatic brain radionecrosis (grade \>=2 defined according to CTCAE scale v5.0).
Assess progression free survival (progression free survival = PFS) at 3 years
Percentage of patients alive and free of disease progression at 3 years after the start of radiotherapy (PFS rate). Progression will be defined as increase in size of treated lesions or appearance of new lesions (according to RANO meningioma criteria)
Secondary outcomes
Overall survival (Overall survival = OS)
Overall survival (OS) will be defined as time between enrollment and death
Incidence of other toxicities
Incidence of other neurological toxicities graded using the CTCAE scale v. 5.0
Concordance between GTV-RM and GTV-PET
Concordance will be measured according to Dice Similarity coefficient
Sponsors and contacts
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