GammaTile + Stupp Protocol for Glioblastoma
(GESTALT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial prohibits the use of other systemic or local anti-cancer medications or treatments, except for TTF (tumor treating fields) before progression. However, anti-angiogenic therapy and steroids are allowed for symptom management. It's best to discuss your specific medications with the trial team to see if they are allowed.
What data supports the effectiveness of the GammaTile + Stupp Protocol treatment for glioblastoma?
Research shows that GammaTile, a type of brachytherapy (internal radiation), is effective in delivering targeted radiation to brain tumors, potentially improving local control and reducing recurrence. Studies indicate that GammaTile is safe and feasible for use in recurrent brain tumors, with no implant-related complications reported in early trials.12345
Is GammaTile Therapy safe for use in humans?
What makes the GammaTile + Stupp Protocol treatment unique for glioblastoma?
The GammaTile + Stupp Protocol is unique because it combines surgically targeted radiation therapy using GammaTile, which delivers radiation directly to the tumor site through cesium-131 seeds embedded in a collagen tile, with standard treatments like surgery, external beam radiation, and chemotherapy. This approach allows for a higher, more localized radiation dose to the tumor bed, potentially improving local control and reducing recurrence compared to traditional methods.12458
What is the purpose of this trial?
This trial tests if adding GammaTile radiation therapy to standard treatment can improve outcomes for patients with newly diagnosed GBM. GammaTile delivers quick, direct radiation to the tumor, which may help control the tumor better and improve survival rates.
Eligibility Criteria
Adults diagnosed with a specific brain cancer called GBM who can undergo surgery to remove the tumor and are able to follow the Stupp protocol (chemotherapy and radiation). They must have good organ function, not be pregnant, agree to use contraception, and cannot have had certain other treatments or conditions that would interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgical Phase
Participants undergo resection and GammaTile implantation
Concomitant Phase
Participants receive external beam radiation therapy (EBRT) and temozolomide (TMZ)
Adjuvant Phase
Participants continue with temozolomide (TMZ) treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- EBRT
- GammaTile radiation therapy implantation
- Surgical tumor resection
- Temozolamide
EBRT is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
- Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others
- Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others
- Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others
- Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others
- Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others
- Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others
Find a Clinic Near You
Who Is Running the Clinical Trial?
GT Medical Technologies, Inc.
Lead Sponsor