Surgery plus intraoperative balloon electronic brachytherapy with the Xoft Axxent system for newly diagnosed glioblastoma.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study combines maximal surgical removal of newly diagnosed glioblastoma with placement of a balloon applicator to deliver intraoperative electronic brachytherapy using the Xoft Axxent (eBx) system. Eligible patients (ages 40–75, KPS ≥70) who have tumors amenable to total or near-total resection and a cavity suitable for the balloon will undergo standard resection followed by targeted radiation delivered directly to the resection cavity during the same operation. The primary focus is safety and feasibility of the device and procedure in the immediate perioperative period, with clinical and imaging follow-up to monitor healing and local tumor control. If tolerated, patients will proceed to standard postoperative management as guided by treating physicians.

Why it matters

Who can join: the full rules

Inclusion 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 tumor.
* 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.

Exclusion Criteria:

* 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.

Where it's running

• Joint-Stock Company European Medical Center
  Moscow, Moscow, Russia Recruiting

Study contacts

• Principal investigator: Aleksey Krivoshapkin, Professor M.D. — Joint-Stock Company European Medical Center
• Study coordinator: Evgeniy Avetisov
• Email: eavetissov@emcmos.ru
• Phone: +7 (925) 288 - 59-29

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.