GammaTile and Stupp in Newly Diagnosed GBM

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

August 17, 2022

Primary Completion Date

December 1, 2027

Study Completion Date

December 1, 2027

Conditions
Glioblastoma
Interventions
DEVICE

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.

Trial Locations (16)

27834

ECU Health Medical Center - Vidant, Greenville

30309

Piedmont Healthcare, Atlanta

32803

Advent Health Orlando, Orlando

33606

Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital, Tampa

45429

Kettering Medical Center, Kettering

46202

Indiana University Office of Clinical Research, Indianapolis

48202

Henry Ford Health System, Detroit

55485

University of Minnesota, Minneapolis

60607

RUSH University, Chicago

63110

St. Louis University Hospital Center, St Louis

66016

University of Kansas Hospital, Kansas City

85251

HonorHeath Scottsdale Osborn Medical Center, Scottsdale

90033

Keck Medicine of USC, Los Angeles

95817

UC Davis Comprehensive Cancer Center, Sacramento

02906

Brown University Health, Providence

Texas

"UTHealth Houston , Memorial Hermann Health System"

Sponsors
All Listed Sponsors
lead

GT Medical Technologies, Inc.

INDUSTRY