Health Condition 1: D320- Benign neoplasm of cerebral meninges
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: This study will include patients who are eighteen years of age or older and have a confirmed diagnosis of an intracranial meningioma, specifically categorized as World Health Organization Grade Two. These patients must have already undergone the safest possible surgical resection to remove as much of the tumor as possible but still have some residual tumor remaining. Additionally, the tumor must be confirmed as belonging to the Hypermitotic Hypermethylated group through DNA methylation profiling.
Exclusion criteria
Exclusion criteria: Patients who are younger than 18 years are excluded. They do not meet the specific volume or radiation dose measurement criteria required to safely deliver the planned marginal dose of treatment. They have received prior radiation therapy to the brain or the base of the skull that would cause overlapping treatment fields. There is evidence that the tumor has spread to areas outside the skull or into the fluid surrounding the brain and spinal cord. The patient has multiple meningiomas rather than a single tumor. The patient has any condition that prevents them from having an MRI, such as a pacemaker or certain metallic implants. The patient is currently pregnant or breastfeeding. The patient suffers from a severe, active medical condition or a psychiatric illness that would make it difficult for them to complete the treatment or attend follow-up appointments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the 3-year cumulative incidence of symptomatic radionecrosis (Grade 3) following dose-escalated radiosurgery in patients with hypermitotic hypermethylated grade 2 meningiomasTimepoint: it is assessed at 6 months every early for 3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the 3-year Progression-Free Survival (PFS) in patients treated with dose-escalated radiosurgery.Timepoint: 3 years;To estimate the 3-year Overall Survival (OS) in patients treated with dose-escalated radiosurgery.Timepoint: 3 years;To evaluate the tumor control rate at 1 and 3 years.Timepoint: 1 year and 3 years;To explore the 3-year Progression-Free Survival rates for both the Proliferative and Hypermetabolic subgroups within the study cohort.Timepoint: 3 year | — |
Countries
India
Contacts
NIMHANS