Randomized Study of Resection and GammaTile Followed by Concurrent External Beam Radiation Therapy (ERBT) and Temozolomide (TMZ) and Adjuvant TMZ Versus Standard of Care in Newly Diagnosed Glioblastoma (GBM)

Sponsor:

GT Medical Technologies, Inc

Sponsor Study ID:

GTM-105

CTO #:

104318

NCT Number:

NCT07195591

Phase:

III

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Brain and Nervous System

Study Objectives:

To compare maximal safe resection followed by a 30-fraction course of external beam radiation therapy (EBRT) with concurrent oral temozolomide followed by adjuvant oral TMZ (tumor treating fields are allowed, but not mandated) (Arm a) versus maximal safe resection with immediate radiation by implantation of GammaTile followed by a 20-fraction course of EBRT with concurrent oral TMZ followed by adjuvant oral TMZ (tumor treating fields are allowed, but not mandated) (Arm B)

eConsent:

Not available

Study Documents:

Open Study Documents
(MUSC NetID required for document access)