Tumor Treating Fields for the Treatment of Brainstem Gliomas

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor	NCT ID:	NCT05310448
Trial Phases:		Protocol IDs:	WINSHIP5412-21 (primary) NCI-2021-09679 STUDY00003027
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05310448

Summary

This clinical trial tests the safety and side effects of tumor treating fields in treating patients with glioma. 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. Tumor treating fields may help shrink tumors in patients with glioma.

Objectives

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 18 hours per day for 12 months in the absence of disease progression or unacceptable toxicity.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.