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New treatment option for Glioblastoma
Official title Combined Treatment of Patients With Newly Diagnosed Glioblastoma Using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System for Intraoperative Balloon Electronic Brachytherapy
ClinicalTrials.gov ID: NCT07141732
What this study is testing
What is Resection of newly diagnosed glioblastoma combined with intraoperative balloon electronic brachytherapy using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System?
Resection of newly diagnosed glioblastoma combined with intraoperative balloon electronic brachytherapy using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Glioblastoma is the most aggressive primary brain tumor due to its highly infiltrative growth pattern, strong proliferative potential, and multiple mechanisms of resistance to treatment . Based on results from multicenter studies, English oncologist Roger Stupp proposed in 2005 a new treatment approach involving initial tumor resection followed by conformal external beam radiation therapy combined with temozolomide, plus subsequent cycles of monochemotherapy with this drug.
- Phase 1: an early, usually small safety study
- Time commitment: about 6 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- The subject's age must be ≥ 40 years but not older than 75 years.
- The subject's Karnofsky Performance Status (KPS) must be ≥ 70%.
- The subject is willing and able to independently provide informed consent for participation in the study.
- The subject has been newly diagnosed with glioblastoma (GB) based on preoperative neuroimaging (contrast-enhanced brain MRI ± amino acid-based...
- Total or near-total resection of the contrast-enhancing tumor portion is feasible.
You likely can't join if
- Multicentric/multifocal glioblastoma growth.
- Infratentorial or leptomeningeal tumor spread.
- Recurrent/progressive glioblastoma.
- Prior cranial radiation therapy.
- Glioblastoma located in or near (≤ 10 mm from) critical brain structures, preventing adequate radiation dose delivery.
- Contrast-enhancing tumor diameter \> 6 cm.
See the full eligibility criteria
- The subject's age must be ≥ 40 years but not older than 75 years.
- The subject's Karnofsky Performance Status (KPS) must be ≥ 70%.
- The subject is willing and able to independently provide informed consent for participation in the study.
- The subject has been newly diagnosed with glioblastoma (GB) based on preoperative neuroimaging (contrast-enhanced brain MRI ± amino acid-based PET/CT) and confirmed by intraoperative histopathological examination of the...
- Total or near-total resection of the contrast-enhancing tumor portion is feasible.
- The expected post-resection cavity size must allow placement of the Axxent Xoft eBx balloon applicator system.
- Women of childbearing potential must have a negative pregnancy test within 7 days before treatment initiation.
- The subject must have a complete blood count (CBC) with or without differential within 7 days before study enrollment, demonstrating adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm³
- Platelets ≥ 75,000 cells/mm³
- Hemoglobin ≥ 10.0 g/dL
- The subject must undergo kidney and liver function tests within 7 days before study enrollment, with the following required parameters:
- Total bilirubin ≤ 2.0 mg/dL, and AST ≤ 2.5 × upper limit of normal (ULN)
- Serum creatinine ≤ 1.8 mg/dL within 14 days before enrollment.
- The subject's urine protein levels must meet the following criteria within 14 days before enrollment:
- Urine protein-to-creatinine ratio (UPCR) \< 1.0, OR
- Dipstick urinalysis ≤ 2+ proteinuria (if \> 2+, a 24-hour urine collection must show ≤ 1 g protein/24h).
- Patients on anticoagulant therapy (e.g., warfarin or low-molecular-weight heparin) must meet all of the following:
- No active bleeding or high-risk bleeding conditions (e.g., tumor involving major vessels or varices).
- Stable INR (typically 2-3) on oral anticoagulants OR stable dose of LMWH for ≥ 14 days before enrollment.
- Multicentric/multifocal glioblastoma growth.
- Infratentorial or leptomeningeal tumor spread.
- Recurrent/progressive glioblastoma.
- Prior cranial radiation therapy.
- Glioblastoma located in or near (≤ 10 mm from) critical brain structures, preventing adequate radiation dose delivery.
- Contrast-enhancing tumor diameter \> 6 cm.
- Active or prior malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ).
- Other intracranial neoplasms (current or history).
- Pregnancy, lactation, or unwillingness to use effective contraception (for women of childbearing potential or sexually active men).
- Contraindications to MRI (with or without gadolinium).
- Non-removable or clinically inoperable cardiac pacemaker/device.
- Contraindications to general anesthesia.
- Concurrent participation in another clinical trial.
- Severe comorbidities, including:
- Unstable angina or congestive heart failure requiring hospitalization (within 6 months).
- Transmural myocardial infarction (within 6 months).
- Stroke or transient ischemic attack (within 6 months).
- Significant vascular disease (aortic/peripheral).
- Active venous/arterial thromboembolism.
- Acute bacterial/fungal infection requiring IV antibiotics.
- COPD exacerbation or respiratory disease interfering with protocol therapy.
- Liver failure causing jaundice/coagulopathy.
- Positive serology for HIV, HBV, HCV, or syphilis.
- Grade ≥ 3 hemorrhage (CTCAE v5.0) within 30 days before enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.