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GammaTile + Stupp Protocol for Glioblastoma (GESTALT Trial)

Phase 4
Recruiting
Research Sponsored by GT Medical Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to receive 5-aminolevulinic acid (5-ALA) or other institutionally standard immunofluorescent-guidance
Karnofsky Performance Scale (KPS) score of ≥ 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12,18 and 24 months
Awards & highlights

GESTALT Trial Summary

This trial will assess the feasibility and tolerability of addingGammaTile radiation therapy as an upfront boost at the time of maximum safe resection, along with the backbone of the current standard of care approach, concomitant and adjuvant temozolomide +/- TTF, for patients with newly diagnosed GBM.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include typical reactions from brain surgery or radiation such as headaches, swelling at the site of implantation, fatigue from chemotherapy, possible blood disorders like low platelet counts or anemia. Each patient's experience may vary.

GESTALT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take a special dye for surgery guidance.
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I am able to care for myself but may not be able to do active work.
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I am able to care for myself and perform daily activities.
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My brain tumor is confirmed to be GBM with IDH mutation.
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I am 18 years old or older.
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My brain tumor can potentially be completely removed by surgery.
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I am using effective birth control during and up to 3 months after the study.
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I am not currently taking any other cancer treatments.

GESTALT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12,18 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12,18 and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall incidence of treatment related (possibly, probably, or definitely) grade ≥3 (CTCAE v5) adverse events in the safety analysis (ITT) population.
Percentage of patients in the Intent to Treat (ITT) population who were able to start the Concomitant Phase (start is defined as first day of EBRT) between 21 and 35 days postoperatively.
Secondary outcome measures
Incidence of treatment related (possibly, probably, or definitely) grade ≥3 (CTCAE v5) adverse events during each phase (surgical phase, concomitant phase, and adjuvant phase, in both the safety analysis (ITT) and PP populations.
Percentage of patients in the per protocol (PP) population who were able to start the Concomitant Phase (start is defined as first day of EBRT) between 21 and 35 days postoperatively.
Percentage of patients lost to attrition after consenting to participate.
+1 more
Other outcome measures
Eastern Cooperative Oncology Group Performance Status Scale
Examine intracranial radiation toxicity outcomes in a population of patients for whom radiobiological modeling was used to combine dose of Cs 131 brachytherapy and EBRT (ITT and PP populations)
Immune Competence
+6 more

GESTALT Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: Resection, GammaTile and Stupp ProtocolExperimental Treatment1 Intervention
Resection, Gamma Tile and Stupp Protocol

Find a Location

Who is running the clinical trial?

GT Medical Technologies, Inc.Lead Sponsor
5 Previous Clinical Trials
1,576 Total Patients Enrolled
2 Trials studying Glioblastoma
1,200 Patients Enrolled for Glioblastoma

Media Library

EBRT Clinical Trial Eligibility Overview. Trial Name: NCT05342883 — Phase 4
Glioblastoma Research Study Groups: Experimental: Resection, GammaTile and Stupp Protocol
Glioblastoma Clinical Trial 2023: EBRT Highlights & Side Effects. Trial Name: NCT05342883 — Phase 4
EBRT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05342883 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for participants of this trial?

"Clinicialtrials.gov indicates that this research is actively seeking participants as of September 19th 2022, the day it was initially posted and most recently updated."

Answered by AI

How many participants are being monitored as part of this investigation?

"Affirmative. According to medical records from clinicaltrials.gov, this research endeavour is actively recruiting individuals for participation. It was first announced on September 19th 2022 and has since been updated with the same date; 61 volunteers are required at a single location."

Answered by AI

What are the ultimate aims of this clinical trial?

"This clinical trial is planned to take place over a period of between 21-35 days and its primary objective is to assess the rate of severe adverse events in both ITT (Intention To Treat) and PP (Per Protocol) populations. Secondary outcomes include the percentage of pre-screened patients that consent, incidence of treatment related grade ≥3 CTCAE v5 side effects in each phase, as well as measuring how many participants from the Per Protocol population were able to start concomitant phase within this time frame."

Answered by AI

What health hazards have been associated with this particular treatment?

"Through the use of our internal rating system, Power has assigned a safety score of 3 to this treatment because it is approved for clinical trials in Phase 4."

Answered by AI

Who else is applying?

What site did they apply to?
Keck Medicine of USC
UC Davis Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
GammaTile and Stupp in Newly Diagnosed GBM
2022. "GammaTile and Stupp in Newly Diagnosed GBM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05342883.
All > Glioblastoma Long Beach
~40 spots leftby Jul 2027
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