Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.

Centro di Riferimento Oncologico - Aviano53 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Meningioma

Interventions

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of brain radionecrosis

Incidence of symptomatic brain radionecrosis (grade \>=2 defined according to CTCAE scale v5.0).

Time frame: up to 13 years

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)

Time frame: up to 13 years

Secondary Outcomes

Overall survival (Overall survival = OS)

Overall survival (OS) will be defined as time between enrollment and death

Time frame: up to 13 years

Incidence of other toxicities

Incidence of other neurological toxicities graded using the CTCAE scale v. 5.0

Time frame: up to 13 years

Concordance between GTV-RM and GTV-PET

Concordance will be measured according to Dice Similarity coefficient

Time frame: up to 13 years

Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts