61 Participants Needed

GammaTile + Stupp Protocol for Glioblastoma

(GESTALT Trial)

Recruiting at 22 trial locations
LC
AH
MA
MA
SP
Overseen BySita Patel, PhD, PharmD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: GT Medical Technologies, Inc.
Must be taking: Temozolomide
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

GammaTile Therapy has been shown to be safe in multiple clinical trials for brain tumors, with no implant-related complications reported in early studies. It has been approved by the FDA for use in both newly diagnosed and recurrent brain tumors, indicating its general safety in humans.24567

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

Willing and able to comply with scheduled visits, treatment plan, and laboratory tests
Satisfactory hematology as evidenced by standard pre-surgery labs
I can understand English or Spanish.
See 11 more

Exclusion Criteria

My surgery will be done in stages.
I have not had any other cancer besides this one in the last 2 years.
My brain tumor has spread into the brainstem or thalamus.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Phase

Participants undergo resection and GammaTile implantation

Immediate
1 visit (in-person)

Concomitant Phase

Participants receive external beam radiation therapy (EBRT) and temozolomide (TMZ)

6 weeks
5 visits per week (in-person)

Adjuvant Phase

Participants continue with temozolomide (TMZ) treatment

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

  • EBRT
  • GammaTile radiation therapy implantation
  • Surgical tumor resection
  • Temozolamide
Trial Overview The trial is testing if adding GammaTile radiation therapy right after surgery for GBM improves outcomes. Patients will receive this new treatment along with standard chemotherapy and radiation (Stupp protocol) to see if it's safe, tolerable, and effective in controlling tumor growth.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Experimental: Resection, GammaTile and Stupp ProtocolExperimental Treatment1 Intervention
Resection, Gamma Tile and Stupp Protocol

EBRT is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸
Approved in United States as External Beam Radiation Therapy for:
  • Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others
🇪🇺
Approved in European Union as External Beam Radiation Therapy for:
  • Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others
🇨🇦
Approved in Canada as External Beam Radiation Therapy for:
  • Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others
🇯🇵
Approved in Japan as External Beam Radiation Therapy for:
  • Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others
🇨🇳
Approved in China as External Beam Radiation Therapy for:
  • Various types of cancer including brain tumors, breast cancer, lung cancer, prostate cancer, and others
🇨🇭
Approved in Switzerland as External Beam Radiation Therapy for:
  • 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

Trials
6
Recruited
1,700+

Findings from Research

GammaTile, a Cesium-131 source embedded in collagen mesh, allows for a higher biological dose of radiation (60 Gy) to be delivered directly to the surgical bed of recurrent glioblastomas, which may enhance treatment effectiveness compared to traditional external beam radiation.
This case report demonstrates the successful combination of GammaTile with hypofractionated external beam radiation therapy (35 Gy) in a patient with recurrent glioblastoma, showing that it is feasible to optimize radiation delivery without causing excessive dose to surrounding healthy tissue.
GammaTile Brachytherapy Combined With External Beam Radiation Therapy for the Treatment of a Partially Resected Secondary Glioblastoma (WHO Grade 4 IDH-Mutant Astrocytoma): Matching External Beam Dose Gradient to Brachytherapy Dose Fall-Off.Peach, MS., Burke, AM., Jo, J., et al.[2021]
In a study of seven patients with recurrent gliomas, GammaTile brachytherapy was found to be safe, with no implant-related postoperative complications reported.
The dosimetry results indicated that six out of seven patients received adequate radiation coverage, suggesting that GammaTile can effectively target recurrent brain tumors while maintaining expected surgical outcomes.
GammaTile for Gliomas: A Single-Center Case Series.Budnick, HC., Richardson, AM., Shiue, K., et al.[2021]
The ROADS trial is a Phase 3 randomized controlled study comparing the effectiveness of post-surgical stereotactic radiotherapy (SRT) to surgically targeted radiation therapy (STaRT) using GammaTile for patients with newly diagnosed metastatic brain tumors.
This trial aims to determine which treatment method provides better outcomes in terms of safety and efficacy for patients undergoing surgery for metastatic brain tumors.
Clinical Trials in Progress: ROADS Trial.Weinberg, J.[2022]

References

GammaTile Brachytherapy Combined With External Beam Radiation Therapy for the Treatment of a Partially Resected Secondary Glioblastoma (WHO Grade 4 IDH-Mutant Astrocytoma): Matching External Beam Dose Gradient to Brachytherapy Dose Fall-Off. [2021]
GammaTile for Gliomas: A Single-Center Case Series. [2021]
Clinical Trials in Progress: ROADS Trial. [2022]
GammaTile®: Surgically targeted radiation therapy for glioblastomas. [2021]
Surgically targeted radiation therapy (STaRT) trials for brain neoplasms: A comprehensive review. [2023]
Safety and efficacy of GammaTile intracranial brachytherapy implanted during awake craniotomy. [2021]
GammaTile® brachytherapy in the treatment of recurrent glioblastomas. [2022]
Treating Recurrent Brain Metastases Using GammaTile Brachytherapy: A Case Report and Dosimetric Modeling Method. [2022]
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