Neoplasms

All Conditions

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

After completion of standard of care radiation therapy, patients wear the Optune device for 18 hours per day for 12 months in the absence of disease progression or unacceptable toxicity.

Optune device

Jim Zhong, MD

India Green

This clinical trial tests the safety and side effects of tumor treating fields in treating patients with gliomas located in the brainstem. Optune is a wearable, portable, treatment that creates low-intensity, wave-like electric fields called tumor treating fields (TTFields), which interfere with cancer cell division. TTFields may prevent growth or decrease size of gliomas in patients

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.

Tumor Treating Fields for the Treatment of Brainstem Gliomas

Tumor Treating Fields: Pilot Study of Adjuvant Treatment for Brainstem Gliomas

Adverse event rates will be summarized descriptively using frequencies and percentages in addition to a tolerability rate defined as composite of any dose-limiting toxicity.

PFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.

Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

OS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median OS will be estimated using the Brookmeyer-Crowley approach.

Spots Global Cancer Trial Database for optune device