Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas

Description

PRIMARY OBJECTIVE:

I. To determine the progression free survival (PFS) based on Response Assessment in Neuro-Oncology (RANO) imaging criteria from start of treatment with concurrent chemoradiation (CRT) and adjuvant temozolomide (TMZ).

SECONDARY OBJECTIVE:

I. To determine the 3-year overall survival (OS) of isocitrate dehydrogenase (IDH) wild-type grade II and grade III gliomas with dose escalation radiation with concurrent chemoradiation therapy.

EXPLORATORY OBJECTIVES:

I. To assess local control patterns (site of 1st progression). II. To evaluate neuro-cognitive function by the Neurocognitive Clinical Trial Battery (CTB).

III. To evaluate the treatment related symptoms, overall symptom impact, and disease related factor groupings utilizing the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT).

IV. To assess the quality of life.

OUTLINE:

Patients receive temozolomide orally (PO) daily and radiation therapy over 5 days a week (weekdays only) for 6 weeks. Beginning 28 days after the last dose of radiation therapy, patients receive temozolomide PO for 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, 5, 7, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months.