Phase III Study Comparing Observation to Radiation Therapy After Complete Surgical Removal of Grade II Meningioma

What this Trial Is About

Researchers are evaluating how well radiation therapy works compared with observation in patients who have a newly diagnosed grade II meningioma that has been completely removed by surgery. This phase III trial aims to determine the clinical benefit of adding radiation therapy after complete tumor removal and also studies overall survival, disease-specific survival, side effects, neurocognitive function, patient-reported outcomes, and biomarker correlations. Participants are randomly assigned to one of two groups. One group undergoes observation with regular MRI scans and blood collection throughout the study. The other group receives intensity-modulated radiation therapy IMRT or proton beam radiation therapy five days a week for about 6.5 to 7 weeks, totaling 33 treatment sessions, unless disease progression or unacceptable side effects occur. Both groups continue to have MRI scans and blood tests during the study. Participants are followed for up to 10 years after treatment or observation, with visits scheduled at 3, 6, and 12 months, then every 6 months for years 2 and 3, and yearly thereafter. The study measures time without disease progression as the main outcome, along with survival rates, adverse events, cognitive function changes, and adherence to treatment protocols. Tissue and blood samples are also collected for ongoing research.

Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery