61
Participants
Start Date
August 17, 2022
Primary Completion Date
December 1, 2027
Study Completion Date
December 1, 2027
Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide)
At the initiation of the surgical phase maximal safe resection will be undertaken, and after 25 + 4 from surgery participants will start the concomitant phase and receive daily temozolomide (TMZ, 75mg/m2) and 20 fractions external beam radiation (EBRT). The EBRT treatment will be to the operative bed and any residual disease identified at the time of the imaging obtained for EBRT planning. The EBRT planning will utilize the GT implant dosimetry with the intent that the dose received from the GT will be accounted for during the EBRT treatment planning process. Twenty-eight days ±7 after the completion of concomitant TMZ and EBRT, participants will enter the adjuvant phase and will be treated with TMZ (150-200mg/m2) for 5 days at the start of every 28- day cycle, for 6 cycles.
ECU Health Medical Center - Vidant, Greenville
Piedmont Healthcare, Atlanta
Advent Health Orlando, Orlando
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital, Tampa
Kettering Medical Center, Kettering
Indiana University Office of Clinical Research, Indianapolis
Henry Ford Health System, Detroit
University of Minnesota, Minneapolis
RUSH University, Chicago
St. Louis University Hospital Center, St Louis
University of Kansas Hospital, Kansas City
HonorHeath Scottsdale Osborn Medical Center, Scottsdale
Keck Medicine of USC, Los Angeles
UC Davis Comprehensive Cancer Center, Sacramento
Brown University Health, Providence
"UTHealth Houston , Memorial Hermann Health System"
Lead Sponsor
GT Medical Technologies, Inc.
INDUSTRY