Tumor Treating Fields for the Treatment of Brainstem Gliomas

Description

PRIMARY OBJECTIVE:

I. To evaluate the safety and tolerability of tumor treating fields in combination with standard of care radiotherapy and chemotherapy in patients with brainstem gliomas.

SECONDARY OBJECTIVE:

I. To evaluate the anti-tumor activity of the combination of radiotherapy, chemotherapy, and tumor treating fields by assessing progression-free survival (PFS), overall response rate, and overall survival (OS).

TERTIARY/EXPLORATORY OBJECTIVE:

I. To assess the effects of the tumor treating fields on neurocognitive function.

OUTLINE:

Beginning after start of standard of care radiation therapy, patients wear the Optune device for at least 18 hours per day for 12 months in the absence of disease progression or unacceptable toxicity.

During study treatment, patients are followed up at 3, 6, 9, and 12 months. After study treatment, patients are followed up every 3-6 months.