This randomized phase III trial studies how well radiation therapy works compared with
observation in treating patients with newly diagnosed grade II meningioma that has been
completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells
and shrink tumors.
I. To determine, in terms of progression-free survival (PFS), the extent of clinical benefit
of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients
with newly diagnosed World Health Organization (WHO) grade II meningioma.
I. Overall survival (OS). II. Disease-specific survival (DSS). III. Toxicity (grade 3+,
exclusive of expected alopecia). IV. Neurocognitive function (NCF). V. Outcomes and patient
reported outcomes (PRO) measurements. VI. Adherence to protocol-specific target and normal
tissue parameters. VII. Concordance measurements of central versus parent-institution
pathology. VIII. Tissue microarray construction, and assessment of pHH3 mitotic index and
molecular correlates to OS.
OUTLINE: Patients are randomized to 1 of 2 arms after undergoing gross total resection.
ARM I: Patients undergo observation.
ARM II: Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33
fractions (59.4 Gy in 33 daily fractions of 1.8 Gy each).
After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6
months for year 2 and 3, then yearly for 10 years.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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