GlioblastomaPhase 2NeoGlioNCT04209790
Neoadjuvant Chemoradiation for Resectable Glioblastoma
A Phase 2 study testing Neoadjuvant chemoradiation and Surgery post Radiation and Temozolomide (benzolamide) in people with Glioblastoma and Surgery, run by Geisinger Clinic at 2 sites in United States.
Trial summary
Preoperative therapy has not been well studied in resectable glioblastoma. This study attempts to prospectively assess the feasibility and efficacy of preoperative chemo radiation in improving local control, as this is the predominant mode of failure in these patients leading to poor outcomes. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Glioblastoma, Surgery, High Grade Glioma
- What is being tested?
- Neoadjuvant chemoradiation and Surgery post Radiation and Temozolomide (benzolamide)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2020to 14 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed GBM with histopathological confirmation.
- Surgically suitable for subtotal or gross total resection as determined by central review.
- Karnofsky Performance Status (KPS)>70
- No contraindication for chemoradiation.
- Complete blood count (CBC)/differential obtained within 28 days prior to registration, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
Show all 13Show fewer
- Platelets ≥ 100,000 cells/mm3;
- Hemoglobin ≥ 8.0 g/dl (Note: the use of transfusion or other intervention to achieve Hgb ≥8.0 g/dl is acceptable)
- Adequate hepatic function within 28 days prior to registration, as defined below:
- Alanine Aminotransferase (ALT) and Aspartate transaminase (AST) ≤ 3 x ULN
- Bilirubin ≤ 1.5 upper limit of normal (ULN)
- Negative serum pregnancy test obtained for females of child-bearing potential within 28 days prior to step 2 registration.
- Ability to get multiplanar contrast enhanced Magnetic Resonance Imaging (MRI)
Who cannot join
- Recurrent, unresectable or multifocal malignant gliomas.
- Any site of distant disease (for example, drop metastases from the GBM tumor site)
- Prior radiation or chemotherapy or radiosensitizers for cancers of the brain and head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide).
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Patents treated on any other therapeutic clinical protocols within 30 days prior to registration.
- Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker, or severe claustrophobia).
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- Severe, active co-morbidity, defined as follows:
- Transmural myocardial infarction within the last 6 months prior to registration
- History of recent myocardial infarction 1month prior
- New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 3 months prior to registration.
- Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is because the treatments involved in this protocol may be significantly immunosuppressive with potentially fatal outcomes in patients already immunosuppressed.
- Any other severe immuno-compromised condition.
- Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
- End-stage renal disease (i.e. on dialysis or dialysis has been recommended).
- Any other major medical illnesses or psychiatric treatments that in the investigator's opinion will prevent administration or completion of protocol therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Geisinger Medical Center
Danville, Pennsylvania, 17822
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
About this study
Official title: Phase II Study of Neoadjuvant Chemoradiation for Resectable Glioblastoma (NeoGlio)
Preoperative therapy has not been well studied in resectable glioblastoma. This study attempts to prospectively assess the feasibility and efficacy of preoperative chemo radiation in improving local control, as this is the predominant mode of failure in these patients leading to poor outcomes.
This Phase II study design would be used to proceed with the study treatment after meeting pre-specified events in the initial phase, with goal being to determine whether the new treatment paradigm is sufficiently promising to warrant a major controlled clinical evaluation against the standard therapy.
Read the detailed description
Neo adjuvant, preoperative chemo radiation has consistently shown improvements in local disease control or organ preservation in many cancers including head and neck, esophageal, rectal, bladder cancers and sarcomas, leading to improvements in overall survival and limb or organ preservation.
This interventional study will be done in two phases using the Simon two-stage Phase II study design. The median progression-free survival of these patients with current standard of care therapy is in the range of 6-8 months (6.9 months in the standard of care). With the proposed trial of surgical resection of the tumor after chemotherapy and radiation the median progression free survival is anticipated to be approximately 11-12 months from subset analysis of available literature and based on prior data on other disease sites. In other words, the 7-month local progression rates is anticipated to decrease from 50% to 25%, or progression free survival improve from 50-75%
- Conditions
- Glioblastoma, Surgery, High Grade Glioma
- Being tested
- Neoadjuvant chemoradiation, Drug Therapy with Temozolomide (benzolamide) (Standard of Care), Surgery post Radiation and Temozolomide (benzolamide)
- Keywords
- Glioblastoma
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemoradiationRadiation
Also called Standard adjuvant therapy
Intensity modulation radiation therapy (IMRT) with a simultaneous integrated boost with Fixed-gantry IMRT, helical tomotherapy, or Vesicular Modulated Arc Therapy (VMAT) can be used. All photon treatments shall be delivered with megavoltage machines of a minimum energy of 6 Megavolt (MV) photons. Selection of the appropriate photon energy(ies) should be based on optimizing the radiation dose distribution within the target volume and minimizing dose to non-target normal tissue.
Drug Therapy with Temozolomide (benzolamide) (Standard of Care)Drug
Also called Neoadjuvant therapy
During Concomitant Radiation Therapy on the same day as the first fraction of radiotherapy. Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days. The drug will be administered orally daily during radiotherapy, as best tolerated by the patient. During weekends without radiotherapy (Saturday and Sunday), the drug will be taken in the morning. The dose will be determined using actual body surface area (BSA) as calculated in square meters at the beginning of the concomitant treatment. The BSA will be calculated from the height obtained at the pretreatment visit. Capsules of temozolomide are available in 5, 20, 100, 140, 180, and 250 mg. The daily dose will be rounded to the nearest 5 mg.
Surgery post Radiation and Temozolomide (benzolamide)Procedure or surgery
Surgical resection of GBM will be done after radiation and Temozolomide treatment.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemoradiation and surgical resection | Other | The experimental part of the study would be this selection of resectable patients and sequencing neoadjuvant chemoradiation prior to surgery. Receives: Radiation: Neoadjuvant chemoradiation; Drug: Drug Therapy with Temozolomide (benzolamide) (Standard of Care); Procedure: Surgery post Radiation and Temozolomide (benzolamide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
No Study Related Undue Toxicity or Progression
Number of participants with no study related undue toxicity or progression within the limits of stage one patients. Toxicity is defined as: progression precluding surgery, unanticipated neurological decompensation, non-completion of neoadjuvant therapy (other than protocol defined dose adjustments or discontinuation), treatment related delay of >6 weeks to surgery, and/or major unforeseen surgical complication requiring repeat surgical intervention including other than non-life-threatening infection like meningitis/encephalitis or septicemia.
Measured: 7 months for each patient from registration
Progression Free Survival
Number of participants with Progression Free Survival/clinical progression with new or worsening neurological symptoms related to the tumor and not due to non-tumor or study related symptoms.
Measured: 7 months after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Apr 2020
- Primary completion14 Sep 2022
- Study completion14 Sep 2022
Why it stopped: Suspended to identify a permanent PI at site level. Decision to Terminate was made on 7/29/25 because no other PI able to take on project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- After standard treatment of Glioblastoma multiforme (GBM) with resection and adjuvant therapy, local failure the dominant pattern of failure. Neo adjuvant therapy consistently provides the potential for improved local control and removal of residual stem cell niches. The hypothesis is that earlier institution of neo adjuvant chemo radiation therapy in GBM would improve local control and potentially overall survival. Involved field radiation is often employed to treat unresectable or sub totally resected GBM. Radiating native GBM is not uncommon as many tumors are not safely resectable due to its location in eloquent brain. Planned neoadjuvant chemo radiation prior to immediate surgical resection in glioblastoma is a novel approach in resectable tumors.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Lacroix, M.D., Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209790
- Sponsor's protocol ID
- 2019-0623
- Acronym
- NeoGlio
- Status last verified
- Oct 2025
- First submitted
- 17 Dec 2019
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Milano MT, Okunieff P, Donatello RS, Mohile NA, Sul J, Walter KA, Korones DN. Patterns and timing of recurrence after temozolomide-based chemoradiation for glioblastoma. Int J Radiat Oncol Biol Phys. 2010 Nov 15;78(4):1147-55. doi: 10.1016/j.ijrobp.2009.09.018. Epub 2010 Mar 6.
PubMed 20207495Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
PubMed 15758009Yarbro JW. Future potential of adjuvant and neoadjuvant therapy. Semin Oncol. 1991 Dec;18(6):613-9. No abstract available.
PubMed 1775978Filatova A, Acker T, Garvalov BK. The cancer stem cell niche(s): the crosstalk between glioma stem cells and their microenvironment. Biochim Biophys Acta. 2013 Feb;1830(2):2496-508. doi: 10.1016/j.bbagen.2012.10.008. Epub 2012 Oct 16.
PubMed 23079585Rycaj K, Tang DG. Cancer stem cells and radioresistance. Int J Radiat Biol. 2014 Aug;90(8):615-21. doi: 10.3109/09553002.2014.892227. Epub 2014 Mar 7.
PubMed 24527669
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant Chemoradiation for Resectable Glioblastoma (NeoGlio)
- ClinicalTrials.gov ID
- NCT04209790
- Acronym / sponsor ID
- NeoGlio / 2019-0623
- Conditions
- Glioblastoma, Surgery, High Grade Glioma
- Keywords
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended to identify a permanent PI at site level. Decision to Terminate was made on 7/29/25 because no other PI able to take on project.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 14 Sep 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preoperative therapy has not been well studied in resectable glioblastoma. This study attempts to prospectively assess the feasibility and efficacy of preoperative chemo radiation in improving local control, as this is the predominant mode of failure in these patients leading to poor outcomes.
This Phase II study design would be used to proceed with the study treatment after meeting pre-specified events in the initial phase, with goal being to determine whether the new treatment paradigm is sufficiently promising to warrant a major controlled clinical evaluation against the standard therapy.
Detailed description
Neo adjuvant, preoperative chemo radiation has consistently shown improvements in local disease control or organ preservation in many cancers including head and neck, esophageal, rectal, bladder cancers and sarcomas, leading to improvements in overall survival and limb or organ preservation.
This interventional study will be done in two phases using the Simon two-stage Phase II study design. The median progression-free survival of these patients with current standard of care therapy is in the range of 6-8 months (6.9 months in the standard of care). With the proposed trial of surgical resection of the tumor after chemotherapy and radiation the median progression free survival is anticipated to be approximately 11-12 months from subset analysis of available literature and based on prior data on other disease sites. In other words, the 7-month local progression rates is anticipated to decrease from 50% to 25%, or progression free survival improve from 50-75%
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After standard treatment of Glioblastoma multiforme (GBM) with resection and adjuvant therapy, local failure the dominant pattern of failure. Neo adjuvant therapy consistently provides the potential for improved local control and removal of residual stem cell niches. The hypothesis is that earlier institution of neo adjuvant chemo radiation therapy in GBM would improve local control and potentially overall survival. Involved field radiation is often employed to treat unresectable or sub totally resected GBM. Radiating native GBM is not uncommon as many tumors are not safely resectable due to its location in eloquent brain. Planned neoadjuvant chemo radiation prior to immediate surgical resection in glioblastoma is a novel approach in resectable tumors.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemoradiation and surgical resection | Other | Radiation: Neoadjuvant chemoradiation, Drug: Drug Therapy with Temozolomide (benzolamide) (Standard of Care), Procedure: Surgery post Radiation and Temozolomide (benzolamide)The experimental part of the study would be this selection of resectable patients and sequencing neoadjuvant chemoradiation prior to surgery. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Newly diagnosed GBM with histopathological confirmation.
- Surgically suitable for subtotal or gross total resection as determined by central review.
- Karnofsky Performance Status (KPS)>70
- No contraindication for chemoradiation.
- Complete blood count (CBC)/differential obtained within 28 days prior to registration, with adequate bone marrow function defined as follows:
Key exclusion criteria (19 listed)
- Recurrent, unresectable or multifocal malignant gliomas.
- Any site of distant disease (for example, drop metastases from the GBM tumor site)
- Prior radiation or chemotherapy or radiosensitizers for cancers of the brain and head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide).
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Patents treated on any other therapeutic clinical protocols within 30 days prior to registration.
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 |
|---|---|---|
| Neoadjuvant chemoradiationAlso: Standard adjuvant therapyIntensity modulation radiation therapy (IMRT) with a simultaneous integrated boost with Fixed-gantry IMRT, helical tomotherapy, or Vesicular Modulated Arc Therapy (VMAT) can be used. All photon treatments shall be delivered with megavoltage machines of a minimum energy of 6 Megavolt (MV) photons. Selection of the appropriate photon energy(ies) should be based on optimizing the radiation dose distribution within the target volume and minimizing dose to non-target normal tissue. | Radiation | Neoadjuvant chemoradiation and surgical resection |
| Drug Therapy with Temozolomide (benzolamide) (Standard of Care)Also: Neoadjuvant therapyDuring Concomitant Radiation Therapy on the same day as the first fraction of radiotherapy. Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days. The drug will be administered orally daily during radiotherapy, as best tolerated by the patient. During weekends without radiotherapy (Saturday and Sunday), the drug will be taken in the morning. The dose will be determined using actual body surface area (BSA) as calculated in square meters at the beginning of the concomitant treatment. The BSA will be calculated from the height obtained at the pretreatment visit. Capsules of temozolomide are available in 5, 20, 100, 140, 180, and 250 mg. The daily dose will be rounded to the nearest 5 mg. | Drug | Neoadjuvant chemoradiation and surgical resection |
| Surgery post Radiation and Temozolomide (benzolamide)Surgical resection of GBM will be done after radiation and Temozolomide treatment. | Procedure or surgery | Neoadjuvant chemoradiation and surgical resection |
Primary outcome
No Study Related Undue Toxicity or Progression
Time frame: 7 months for each patient from registration
Number of participants with no study related undue toxicity or progression within the limits of stage one patients. Toxicity is defined as: progression precluding surgery, unanticipated neurological decompensation, non-completion of neoadjuvant therapy (other than protocol defined dose adjustments or discontinuation), treatment related delay of >6 weeks to surgery, and/or major unforeseen surgical complication requiring repeat surgical intervention including other than non-life-threatening infection like meningitis/encephalitis or septicemia.
Progression Free Survival
Time frame: 7 months after completion of therapy
Number of participants with Progression Free Survival/clinical progression with new or worsening neurological symptoms related to the tumor and not due to non-tumor or study related symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20207495Milano MT, Okunieff P, Donatello RS, Mohile NA, Sul J, Walter KA, Korones DN. Patterns and timing of recurrence after temozolomide-based chemoradiation for glioblastoma. Int J Radiat Oncol Biol Phys. 2010 Nov 15;78(4):1147-55. doi: 10.1016/j.ijrobp.2009.09.018. Epub 2010 Mar 6.
- Background: PubMed 15758009Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
- Background: PubMed 1775978Yarbro JW. Future potential of adjuvant and neoadjuvant therapy. Semin Oncol. 1991 Dec;18(6):613-9. No abstract available.
- Background: PubMed 23079585Filatova A, Acker T, Garvalov BK. The cancer stem cell niche(s): the crosstalk between glioma stem cells and their microenvironment. Biochim Biophys Acta. 2013 Feb;1830(2):2496-508. doi: 10.1016/j.bbagen.2012.10.008. Epub 2012 Oct 16.
- Background: PubMed 24527669Rycaj K, Tang DG. Cancer stem cells and radioresistance. Int J Radiat Biol. 2014 Aug;90(8):615-21. doi: 10.3109/09553002.2014.892227. Epub 2014 Mar 7.
- 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.
Michel Lacroix, M.D. principal investigator
Geisinger Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant chemoradiation and Surgery post Radiation and Temozolomide (benzolamide) in people with Glioblastoma and Surgery, run by Geisinger Clinic at 2 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 13 inclusion and 19 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: stopped early, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
No Study Related Undue Toxicity or Progression (time frame: 7 months for each patient from registration). 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?
On the ClinicalTrials.gov record for NCT04209790, which also lists 5 linked publications.
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 10 Nov 2025.