GlioblastomaPhase 4GESTALTNCT05342883
GammaTile and Stupp in Newly Diagnosed GBM
A Phase 4 study testing Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide) in people with Glioblastoma, run by GT Medical Technologies, Inc. at 16 sites in United States.
Trial summary
In summary, standard of care postoperative chemoradiation for patients with newly diagnosed GBM does not routinely provide durable local control or prolonged overall survival. As discussed above it seems unlikely that patient outcomes will be significantly improved with radiation dose escalation given at the time of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 16 sitesUnited States
- Study dates
- 17 Aug 2022to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must be ≥ 18 years of age
- Histopathological and molecular confirmation of newly diagnosed GBM using IDH mutation testing (such as immunohistochemistry for IDH1 R132H) must be performed as part of SOC. A central lab will perform cytogenetics testing. Note: In patients without prior biopsy, diagnosis will be suspected preoperatively, but must be confirmed by molecular testing (i.e., must be IDH wild type). Patients with confirmed pathology from biopsy prior to enrollment are able to participate if they meet all other study requirements. Enrolled patients not ultimately confirmed to have molecular GBM or are found to have IDH mutated tumors after resection and GT placement (if appropriate), will be followed for safety. If tested before screening, patients known to have IDH mutated tumors should not be invited to participate or consented/enrolled.
- Adequate tissue for central submission to determine methylation promoter status. Patients with either methylated or unmethylated MGMT promoter status are included, and this status must be confirmed by central pathology review. Note: Patients with tissue that is insufficient or inadequate for analysis, fails MGMT testing, or has indeterminate MGMT promoter status will receive GT (if indicated) and will be part of the ITT/safety population but will be excluded from the PP population analyses.
- A supratentorial tumor that in the opinion of the enrolling neurosurgeon is a) amenable to attempted gross total resection (GTR) and b) has a maximum preoperative diameter of 6 cm or less when considering all tumor planned for resection (enhancing and non-enhancing). If multifocal, must be fully resectable in one operative bed. Prior diagnostic biopsy allowed. Surgical protocol will follow current institutional standards. If intraoperative MRI is utilized, details will be captured.
- Able to receive 5-aminolevulinic acid (5-ALA, Gleolan) or other institutionally standard immunofluorescent-guidance such as fluorescein, prior to surgery to optimize GTR of enhancing tumor.
- Patient is appropriate candidate to receive SOC treatment for newly diagnosed GBM as usually practiced (Stupp protocol with at least 6 cycles and up to 12 cycles of TMZ).
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- Concomitant systemic or local anti-cancer medications or treatments are prohibited in this study (with the exception of TTF) before progression.
- Anti-angiogenic therapy (e.g., bevacizumab and its biosimilars) or steroid use is allowed for symptom management (e.g., brain edema or symptomatic pseudoprogression) as per institutional standard. Note: For both agents, utilization of the lowest useful doses and shortest useful courses are encouraged. At failure, tumor therapeutic dose of anti-angiogenic therapy (e.g., bevacizumab and its biosimilars) or other therapies can be utilized for treatment at the investigators' discretion.
- Karnofsky Performance Scale (KPS) score of ≥ 70.
- Eastern Cooperative Oncology Group Performance Score (ECOG-PS) of 0-2.
- Ability to understand and the willingness to sign (personally or by a legally authorized representative) the written IRB approved informed consent document prior to performance of any study-related procedures.
- Ability to understand English or Spanish.
- Patients must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests and accessible for follow-up after treatment termination.
- Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment.
- Satisfactory hematology as evidenced by standard pre-surgery labs:
- Hemoglobin ≥ 10 g/dl
- Leukocytes ≥ 2,000/mm3
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Platelets ≥ 100,000/mm3
- Total bilirubin ≤ 2.0 x institutional/lab upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 x ULN OR creatinine clearance (CrCl) ≥ 50mL/min (if using the Cockcroft-Gault formula)
- Absolute lymphocyte count between 1,000 and 4,800 per microliter of blood.
Who cannot join
- Known to be IDH mutated glioma by prior biopsy.
- Patients not appropriate for concomitant or maintenance temozolomide.
- Previous chemotherapy or radiotherapy to the head or neck region resulting in overlapping fields or prior surgery to the brain to resect other brain tumors.
- Staged surgery planned (prior biopsy allowed).
- Bilateral tumors, or multi-focal tumors that cannot be encompassed in one operative field.
- Enhancing extension into brainstem or thalamus, or significant invasion into the corpus callosum that would preclude a high likelihood of GTR.
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- Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ) unless disease free for a minimum of 2 years
- Definitive clinical or radiologic evidence of cancer outside the brain (excluding nonmelanomatous skin cancer, or other types of indolent cancers) not needing active treatment within the past 2 years. Contact the Medical Monitor to review any inquiries on indolent cancers allowed.
- Concomitant systemic or local anti-cancer medications or treatments in use or planned (with the exception of TTF before progression or on protocol TMZ).
- Planned use of adjuvant anti-angiogenic therapy (e.g., bevacizumab and its biosimilars) specifically for tumor treatment
- Enrollment in another investigational study or planned use of investigational therapies. Note: Experimental therapies or enrollment in a subsequent study are allowed after a patient on study has a local recurrence or distant brain failure.
- Patients with contraindication to MRI or CT
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide, bovine -derived collagen, 5-ALA or other institutionally standard immunofluorescent-guidance compounds, such as fluorescein.
- Participants with severe intercurrent illness that will prohibit subsequent chemotherapy and radiotherapy including, but not limited to, unstable systemic disease including ongoing or active infection, COVID-19, uncontrolled hypertension, serous cardiac arrythmia requiring medication, acute cardiovascular disease or clinically manifested myocardial insufficiency or history of myocardial infarction during the past 6 months prior to screening, severe psychiatric illness or other illness that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and adverse events of the prescribed regimens.
- Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine test or serum beta human chorionic gonadotrophin (b-HCG) documented no greater than 14 days prior to study registration unless they are surgically sterile (e.g. oophorectomy, hysterectomy, tubal ligation) or menopausal. Menopause is defined as 12 months of amenorrhea in a woman over 45 in the absence of possible causes for amenorrhea (e.g., low body fat, hormonal imbalances, etc.)
- Any concomitant therapy (e.g., strict ketogenic diet, high dose vitamin C) that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of any of the study treatments.
- History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent.
- Participants who, in the investigator's opinion, are unable to understand the protocol or to give informed consent (personally or by a legally authorized representative), have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Piedmont Healthcare
Atlanta, Georgia, 30309
RUSH University
Chicago, Illinois, 60607
Henry Ford Health System
Detroit, Michigan, 48202
ECU Health Medical Center - Vidant
Greenville, North Carolina, 27834
UTHealth Houston | Memorial Hermann Health System
Houston, Texas, 77030
Indiana University Office of Clinical Research
Indianapolis, Indiana, 46202
University of Kansas Hospital
Kansas City, Kansas, 66016
Kettering Medical Center
Kettering, Ohio, 45429
Keck Medicine of USC
Los Angeles, California, 90033
University of Minnesota
Minneapolis, Minnesota, 55485
Advent Health Orlando
Orlando, Florida, 32803
Brown University Health
Providence, Rhode Island, 02906
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
HonorHeath Scottsdale Osborn Medical Center
Scottsdale, Arizona, 85251
St. Louis University Hospital Center
St Louis, Missouri, 63110
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: Pilot Study of Resection and GammaTile Followed by Concomitant External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant in Newly Diagnosed Glioblastoma (GBM)
In summary, standard of care postoperative chemoradiation for patients with newly diagnosed GBM does not routinely provide durable local control or prolonged overall survival. As discussed above it seems unlikely that patient outcomes will be significantly improved with radiation dose escalation given at the time of the EBRT boost. However, as most failures are local, improving LC could potentially improve the OS of patients. To do this, we propose a shift in the traditional radiation paradigm. This study will assess the feasibility and tolerability of adding GT 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. GT, a novel brain brachytherapy device utilizing Cs-131 embedded in bioresorbable collagen tiles, offers a more sophisticated carrier and a shorter half-life radioisotope, Cs-131. Use of this device allows for radiation initiation at an earlier time point and a more rapid dose delivery and possibly more effective tumor control particularly for rapidly proliferating tumors such as GBM. Two prospective studies have demonstrated the safety and efficacy of re-irradiation with GT in patients with recurrent GBM. The overarching goal of this single-arm, open label phase 4 study is to determine the feasibility and tolerability of treating patients with GammaTile in combination with the Stupp Protocol and how to proceed with testing this treatment in a future, larger, randomized clinical study. The aims of the study are to demonstrate that the use of GammaTile at the time of surgery is well tolerated and does not delay the start of the Stupp protocol. Efficacy outcomes (e.g., LC, OS, PFS) will also be described.
Read the detailed description
This study seeks to explore if GT, given its unique radiobiological and physical characteristics, may permit safe dose escalation and intensification and thereby provide a benefit to newly diagnosed GBM patients in terms of OS and LC when incorporated into the framework of the Stupp protocol. In this study, GT is utilized as an upfront boost at the time of maximum safe resection and dosimetrically integrated into what is otherwise standard of care therapy.
Patients in this study will receive doses from two different forms of radiation treatment, initially from Cs-131 BT with GT and subsequently from fractionated EBRT. In order to ensure both patient safety and adequacy of treatment, we have chosen to stipulate and evaluate the coverage of the tumor volumes and OARs using the doses combined from both these treatments. The intention is that with this methodology the doses received by the target volumes and relevant OARs from the implanted Cs-131 will be accounted for during EBRT treatment planning. This dose combination, accomplished using radiobiological modeling, is frequently undertaken in breast, prostate, and gynecological malignancies. To provide oversight and planning feedback, the first three patients enrolled at each site will undergo review by the Clinical Oversight Committee (COC) at two points for each patient, once after the GT implant, and before starting EBRT treatment.
- Conditions
- Glioblastoma
- Being tested
- Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide)
- Keywords
- Glioblastoma, Newly Diagnosed, Stupp, GammaTile, External Beam Radiation Therapy, Temozolomide, Resection, Brain, Tumor, EBRT, Glioma
- Medical subject headings
- Glioblastoma, Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide)Device
At the initiation of the surgical phase maximal safe resection will be undertaken, and after 25 + 4 from surgery participants will start the concomitant phase and receive daily temozolomide (TMZ, 75mg/m2) and 20 fractions external beam radiation (EBRT). The EBRT treatment will be to the operative bed and any residual disease identified at the time of the imaging obtained for EBRT planning. The EBRT planning will utilize the GT implant dosimetry with the intent that the dose received from the GT will be accounted for during the EBRT treatment planning process. Twenty-eight days ±7 after the completion of concomitant TMZ and EBRT, participants will enter the adjuvant phase and will be treated with TMZ (150-200mg/m2) for 5 days at the start of every 28- day cycle, for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Resection, GammaTile and Stupp Protocol | Other | Resection, Gamma Tile and Stupp Protocol Receives: Device: Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Feasibility of using GammaTiles in patients who will also be treated with the Stupp Protocol.
Measured: 21-35 days
Overall incidence of treatment related (possibly, probably, or definitely) grade ≥3 (CTCAE v5) adverse events in the safety analysis (ITT) population.
Safety of treating patients treated with GammaTiles in addition to the Stupp protocol.
Measured: 24 months
Secondary outcomes (4)
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.
Feasibility of using GammaTiles in patients who will also be treated with the Stupp Protocol.
Measured: 21-35 days
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.
Secondary safety endpoint-assessment of safety in those patients who were treated per protocol
Measured: 24 months
Percentage of pre-screened patients consenting to participate in the study.
Assessment of ease of enrollment.
Measured: Pre-Screening to Consent
Percentage of patients lost to attrition after consenting to participate.
Assessment of attrition
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start17 Aug 2022
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention is the addition of GammaTile radiation therapy to the standard of care Stupp Protocol treatment of newly diagnosed GBM patients.
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GT Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342883
- Sponsor's protocol ID
- GTM-103
- Acronym
- GESTALT
- Status last verified
- Sep 2025
- First submitted
- 6 Apr 2022
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Resection and GammaTile Followed by Concomitant External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant in Newly Diagnosed Glioblastoma (GBM)
- ClinicalTrials.gov ID
- NCT05342883
- Acronym / sponsor ID
- GESTALT / GTM-103
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Newly Diagnosed, Stupp, GammaTile, External Beam Radiation Therapy, Temozolomide, Resection, Brain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- GT Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In summary, standard of care postoperative chemoradiation for patients with newly diagnosed GBM does not routinely provide durable local control or prolonged overall survival. As discussed above it seems unlikely that patient outcomes will be significantly improved with radiation dose escalation given at the time of the EBRT boost. However, as most failures are local, improving LC could potentially improve the OS of patients. To do this, we propose a shift in the traditional radiation paradigm. This study will assess the feasibility and tolerability of adding GT 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. GT, a novel brain brachytherapy device utilizing Cs-131 embedded in bioresorbable collagen tiles, offers a more sophisticated carrier and a shorter half-life radioisotope, Cs-131. Use of this device allows for radiation initiation at an earlier time point and a more rapid dose delivery and possibly more effective tumor control particularly for rapidly proliferating tumors such as GBM. Two prospective studies have demonstrated the safety and efficacy of re-irradiation with GT in patients with recurrent GBM. The overarching goal of this single-arm, open label phase 4 study is to determine the feasibility and tolerability of treating patients with GammaTile in combination with the Stupp Protocol and how to proceed with testing this treatment in a future, larger, randomized clinical study. The aims of the study are to demonstrate that the use of GammaTile at the time of surgery is well tolerated and does not delay the start of the Stupp protocol. Efficacy outcomes (e.g., LC, OS, PFS) will also be described.
Detailed description
This study seeks to explore if GT, given its unique radiobiological and physical characteristics, may permit safe dose escalation and intensification and thereby provide a benefit to newly diagnosed GBM patients in terms of OS and LC when incorporated into the framework of the Stupp protocol. In this study, GT is utilized as an upfront boost at the time of maximum safe resection and dosimetrically integrated into what is otherwise standard of care therapy.
Patients in this study will receive doses from two different forms of radiation treatment, initially from Cs-131 BT with GT and subsequently from fractionated EBRT. In order to ensure both patient safety and adequacy of treatment, we have chosen to stipulate and evaluate the coverage of the tumor volumes and OARs using the doses combined from both these treatments. The intention is that with this methodology the doses received by the target volumes and relevant OARs from the implanted Cs-131 will be accounted for during EBRT treatment planning. This dose combination, accomplished using radiobiological modeling, is frequently undertaken in breast, prostate, and gynecological malignancies. To provide oversight and planning feedback, the first three patients enrolled at each site will undergo review by the Clinical Oversight Committee (COC) at two points for each patient, once after the GT implant, and before starting EBRT treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention is the addition of GammaTile radiation therapy to the standard of care Stupp Protocol treatment of newly diagnosed GBM patients.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Resection, GammaTile and Stupp Protocol | Other | Device: Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide)Resection, Gamma Tile and Stupp Protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- All patients must be ≥ 18 years of age
- Histopathological and molecular confirmation of newly diagnosed GBM using IDH mutation testing (such as immunohistochemistry for IDH1 R132H) must be performed as part of SOC. A central lab will perform cytogenetics testing. Note: In patients without prior biopsy, diagnosis will be suspected preoperatively, but must be confirmed by molecular testing (i.e., must be IDH wild type). Patients with confirmed pathology from biopsy prior to enrollment are able to participate if they meet all other study requirements. Enrolled patients not ultimately confirmed to have molecular GBM or are found to have IDH mutated tumors after resection and GT placement (if appropriate), will be followed for safety. If tested before screening, patients known to have IDH mutated tumors should not be invited to participate or consented/enrolled.
- Adequate tissue for central submission to determine methylation promoter status. Patients with either methylated or unmethylated MGMT promoter status are included, and this status must be confirmed by central pathology review. Note: Patients with tissue that is insufficient or inadequate for analysis, fails MGMT testing, or has indeterminate MGMT promoter status will receive GT (if indicated) and will be part of the ITT/safety population but will be excluded from the PP population analyses.
- A supratentorial tumor that in the opinion of the enrolling neurosurgeon is a) amenable to attempted gross total resection (GTR) and b) has a maximum preoperative diameter of 6 cm or less when considering all tumor planned for resection (enhancing and non-enhancing). If multifocal, must be fully resectable in one operative bed. Prior diagnostic biopsy allowed. Surgical protocol will follow current institutional standards. If intraoperative MRI is utilized, details will be captured.
- Able to receive 5-aminolevulinic acid (5-ALA, Gleolan) or other institutionally standard immunofluorescent-guidance such as fluorescein, prior to surgery to optimize GTR of enhancing tumor.
Key exclusion criteria (18 listed)
- Known to be IDH mutated glioma by prior biopsy.
- Patients not appropriate for concomitant or maintenance temozolomide.
- Previous chemotherapy or radiotherapy to the head or neck region resulting in overlapping fields or prior surgery to the brain to resect other brain tumors.
- Staged surgery planned (prior biopsy allowed).
- Bilateral tumors, or multi-focal tumors that cannot be encompassed in one operative field.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide)At the initiation of the surgical phase maximal safe resection will be undertaken, and after 25 + 4 from surgery participants will start the concomitant phase and receive daily temozolomide (TMZ, 75mg/m2) and 20 fractions external beam radiation (EBRT). The EBRT treatment will be to the operative bed and any residual disease identified at the time of the imaging obtained for EBRT planning. The EBRT planning will utilize the GT implant dosimetry with the intent that the dose received from the GT will be accounted for during the EBRT treatment planning process. Twenty-eight days ±7 after the completion of concomitant TMZ and EBRT, participants will enter the adjuvant phase and will be treated with TMZ (150-200mg/m2) for 5 days at the start of every 28- day cycle, for 6 cycles. | Device | Experimental: Resection, GammaTile and Stupp Protocol |
Primary outcome
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.
Time frame: 21-35 days
Feasibility of using GammaTiles in patients who will also be treated with the Stupp Protocol.
Overall incidence of treatment related (possibly, probably, or definitely) grade ≥3 (CTCAE v5) adverse events in the safety analysis (ITT) population.
Time frame: 24 months
Safety of treating patients treated with GammaTiles in addition to the Stupp protocol.
4 secondary outcomes
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.
Time frame: 21-35 days
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.
Time frame: 24 months
Percentage of pre-screened patients consenting to participate in the study.
Time frame: Pre-Screening to Consent
Percentage of patients lost to attrition after consenting to participate.
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide) in people with Glioblastoma, run by GT Medical Technologies, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 21-35 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.