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)

Date Added
August 28th, 2026
PRO Number
Pro00151624
Researcher
Charlotte Rivers

List of Studies


Keywords
Cancer, Cancer/Brain, Men's Health, Women's Health
Summary

The BRIDGES Clinical Trial (GTM-105) is a phase 3 clinical trial for people who have been newly diagnosed with a glioblastoma (GBM) brain tumor and need surgery. The purpose of this study is to find out if adding GammaTile® during surgical removal of a brain tumor improves survival outcomes compared to standard of care treatment. GammaTile is an FDA-cleared, implantable radiation therapy device placed directly in the surgical cavity at the time of tumor removal surgery. Each GammaTile is made of a 2 cm × 2 cm collagen square that contains four radioactive sources (about the size of a grain of rice). Once implanted, GammaTile begins delivering radiation immediately, right where the tumor was removed. Participants will be randomized into one of two groups (like flipping a coin), with 2 participants being randomized to receive GammaTile for every 1 participant receiving standard care. Participants randomized into the standard care arm will undergo tumor removal surgery followed by 6 weeks of external beam radiation therapy (EBRT) and oral chemotherapy (temozolomide, TMZ), followed by additional cycles of TMZ. Participants in the GammaTile arm will have the GammaTile placed into their surgical site, and also receive all the standard care treatments. However, the radiation course will be four weeks instead of six weeks, because GammaTile will deliver part of the radiation dose. Participants can expect to be enrolled in this trial for up to three years. The most common side effects from the procedures in this trial include radiation brain injury, surgical complications, infections and fatigue.

Both external radiation and GT are FDA cleared for the treatment of malignant (cancerous) brain tumors and available to patients. The experimental part of the study is comparing standard of care to standard of care plus GT for this type of brain tumor.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)

Date Added
October 21st, 2025
PRO Number
Pro00146438
Researcher
Charlotte Rivers

List of Studies


Keywords
Cancer/Brain
Summary

This study is for adult patients with large brain metastases. The purpose of this study is to compare two different radiation therapy dose treatments: staged stereotactic radiosurgery (SSRS) and fractionated stereotactic radiotherapy (FSRT). Both treatment options are currently used as standard of care. Participation in this study will include standard of care visits along with questionnaires completed for research purposes.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



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