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Radiation Therapy

SRT vs GammaTile Therapy for Brain Tumor

Phase 3
Recruiting
Led By Jeffrey Weinberg, MD
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
One to four newly diagnosed brain metastases, identified on the screening MRI, from an extracranial primary tumor
KPS score of ≥70
Must not have
Age <18 years
KPS<70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the efficacy and safety of two treatments for metastatic tumors.

Who is the study for?
Adults over 18 with 1-4 new brain metastases from another cancer, where one lesion is set for surgery and measures between 2.5cm to 5cm. Other lesions must be smaller than 4cm and not near critical areas like the optic chiasm or brainstem. Participants need a good performance status (KPS ≥70), expected to live at least six more months, able to undergo MRI with contrast, have proper kidney and liver function, use contraception if of childbearing potential, and understand English or Spanish.
What is being tested?
This study compares two treatments after surgical removal of certain brain tumors: GammaTile therapy given during surgery versus standard Stereotactic Radiation Therapy (SRT) done weeks later. It's a randomized trial which means patients are put into groups by chance.
What are the potential side effects?
Potential side effects may include typical reactions related to radiation such as fatigue, skin irritation at the treatment site, headaches, nausea, swelling in the treated area of the brain which could affect cognition or other neurological functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have 1-4 new brain tumors from cancer that started elsewhere.
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I am mostly able to care for myself.
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My brain scan shows all non-primary cancer spots are smaller than 4.0 cm.
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My cancer spread is more than 5mm away from the optic nerve and not in my brainstem.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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My daily activity is significantly limited due to my health.
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My cancer is a type of germ cell tumor, small cell carcinoma, or lymphoma.
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I have had whole-brain radiation therapy for brain metastases.
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My cancer has spread to the lining of my brain and spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surgical bed recurrence-free survival (SB-RFS) from the time of randomization up to 2 years post radiation.
Secondary study objectives
Barthel ADL
Controlled Oral Word Association Test (COWAT)
Functional Assessment of Cancer Therapy-Brain (FACT-Br)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Surgical Resection and GammaTile TherapyExperimental Treatment1 Intervention
Surgical Resection and GammaTile Therapy
Group II: Surgical Resection and Stereotactic Radiation TherapyActive Control1 Intervention
Surgical Resection and Stereotactic Radiation Therapy

Find a Location

Who is running the clinical trial?

GT Medical Technologies, Inc.Lead Sponsor
5 Previous Clinical Trials
1,457 Total Patients Enrolled
Jeffrey Weinberg, MDPrincipal InvestigatorMD Anderson Cancer Center, Houston, TX
3 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04365374 — Phase 3
Brain Tumor Research Study Groups: Surgical Resection and GammaTile Therapy, Surgical Resection and Stereotactic Radiation Therapy
Brain Tumor Clinical Trial 2023: Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) Highlights & Side Effects. Trial Name: NCT04365374 — Phase 3
Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04365374 — Phase 3
~42 spots leftby Dec 2025
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