Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation of radiation therapy, based on somatostatin receptor PET imaging | Experimental | Radiation treatment with higher doses than the standard and defined using PET imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose escalation of radiation therapy, based on somatostatin receptor PET imaging | Radiation | Radiation treatment with higher doses than the standard and defined using PET imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of brain radionecrosis | Incidence of symptomatic brain radionecrosis (grade >=2 defined according to CTCAE scale v5.0). | 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) | up to 13 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (Overall survival = OS) | Overall survival (OS) will be defined as time between enrollment and death | up to 13 years |
| Incidence of other toxicities | Incidence of other neurological toxicities graded using the CTCAE scale v. 5.0 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Vinante | Contact | 0434 659855 | lorenzo.vinante@cro.it | |
| Maurizio Mascarin | Contact | mascarin@cro.it |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Vinante | Centro di Riferimento Oncologico di Aviano (CRO) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro di Riferimento Oncologico di Aviano (CRO) | Recruiting | Aviano | Pordenone | 33081 | Italy |
Not provided
| ID | Term |
|---|---|
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 13 years |
| Concordance between GTV-RM and GTV-PET | Concordance will be measured according to Dice Similarity coefficient | up to 13 years |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |