Meningioma
Conditions
Brief summary
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.
Interventions
RADIATIONDose escalation of radiation therapy, based on somatostatin receptor PET imaging
Radiation treatment with higher doses than the standard and defined using PET imaging
Sponsors
Centro di Riferimento Oncologico - Aviano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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; * Not previous brain-level radiotherapy; * Performance status: ECOG=0-2.
Exclusion criteria
* 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; * Inability to perform MRI with MoC or PET.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of brain radionecrosis | up to 13 years | 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 | up to 13 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (Overall survival = OS) | up to 13 years | Overall survival (OS) will be defined as time between enrollment and death |
| Incidence of other toxicities | up to 13 years | Incidence of other neurological toxicities graded using the CTCAE scale v. 5.0 |
| Concordance between GTV-RM and GTV-PET | up to 13 years | Concordance will be measured according to Dice Similarity coefficient |
Countries
Italy
Contacts
Primary ContactLorenzo Vinante
Backup ContactMaurizio Mascarin
Outcome results
None listed