Brain IORT

Brain Tumor Treatment with Xoft IORT | Intraoperative Radiation Therapy

Worldwide, almost 297,000 cases of brain and nervous system tumors are diagnosed per year.1 Glioblastoma (GBM) is the most common and aggressive type of malignant primary brain tumor, with a median survival of 10-12 months. Treatment for brain tumors typically involves surgical removal, followed by radiation therapy or chemotherapy.2,3

Xoft brain IORT is a promising treatment option that may offer better outcomes for patients, with minimal side effects, compared to traditional radiation therapy. For the treatment of certain types of brain tumors, IORT with the Xoft System may allow appropriately selected patients to potentially replace weeks of post-operative external beam radiation therapy (EBRT) with a single fraction of radiation.

IORT with the Xoft System allows radiation oncologists and surgeons to work together to deliver a full course of radiation treatment in one day, at the time of surgery, while the patient is under anesthesia. Once the tumor has been surgically removed, the Xoft System’s miniature x-ray source is inserted inside a flexible balloon-shaped applicator, which is then placed inside the tumor cavity, filled with saline, and used to deliver a single dose of radiation directly to the tumor bed.

The Xoft System is FDA-cleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body. It uses a miniaturized x-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site, while minimizing risk of damage to healthy tissue in nearby areas of the body.

Advantages of the Xoft System

The inflatable balloon provides a minimally invasive approach, fast procedure implementation, and an easy workflow Optimized adherence of the inflated balloon to the resected cavity 50 kV System allows a significant sparing of the healthy tissue prone to dose escalation and longer OS and loc PFS in patients with GBM relapse

Brain IORT with the Xoft System is a groundbreaking procedure that has potential to extend lives and address a significant unmet need in the treatment of several types of cancers including metastatic brain tumors and GBM.

Xoft Intraoperative Radiation Therapy (IORT) for Brain Cancer: Local Tumor Control in Patients with Recurrent Glioblastoma

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Join Professor Krivoshapkin & Dr. Gaytan for an informative product showcase discussing Neuro IORT and the benefits it offers to physicians, facilities and patients.

Featured Panelists

Alexey Krivoshapkin, PhDHead of Neurosurgery branch of Neurology and Neurosurgery School, MD, Professor, Neurosurgeon at the European Medical Center in Moscow, RussiaAlexey Gaytan, MD, PhDNeurosurgeon at the European Medical Center in Moscow, Russia

Learn more about the the promising preliminary results of IORT for Brain Cancer

Featuring Alexey Krivoshapkin, MD, PhD

Professor, Head of Neurosurgery branch of Neurology and Neurosurgery School

Neurosurgeon at the European Medical Center in Moscow, Russia

Supporting Clinical Research

The Xoft System is currently being studied for the treatment of multiple types of brain tumors in leading institutions worldwide. Following please find details of ongoing research:

  • Researchers at the European Medical Center (EMC) in Moscow, one of the largest private medical clinics in Russia and an international leader in comprehensive care and oncology, are researching Xoft brain IORT for the treatment of recurrent glioblastoma multiforme (GBM). In a matched pair study, a total of 30 patients were treated with recurrent GBM between August 2016 and June 2019. All patients underwent maximal safe resection; patients were divided into IORT and EBRT groups. The IORT group (A) was treated with a single fraction of radiation immediately following surgical resection, without chemotherapy or temozolomide following surgery. The comparison group (B) was treated with routine postoperative adjuvant chemotherapy +/- concomitant or sequential EBRT.
  • According to positive clinical research submitted to the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program in May 2020 by Nidal Salim, MD, radiation oncologist and head of the radiotherapy center at the EMC, median overall survival (OS) was 27 months in the IORT group, versus 21 months in the EBRT group. The local progression free survival (locPFS) range for the IORT group was between 3.5 to 39 months, versus 2 to 10 months in the EBRT group. As of December 2019, 8 patients were alive out of the IORT group, whereas none of the patients of the EBRT group survived. This research will be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program.
  • Positive preliminary clinical data on Xoft IORT were presented at the European Association of Neurosurgical Societies (EANS) Congress in Dublin, Ireland in September 2019 by Alexey Gaytan, MD, PhD, neurosurgeon at the EMC. Median overall survival (OS) in the IORT group was 24 months; OS for the EBRT group was 21 months. As of September 2019, nine patients were still alive from the IORT group, whereas none of the patients from the EBRT group survived.
  • Researchers at the James Graham Brown Cancer Center at the University of Louisville are currently conducting a clinical trial on IORT for patients with large brain metastases treated with neurological resection with the Xoft System. In February 2020, the first metastatic brain tumor was treated in the U.S. with intraoperative radiation therapy (IORT) using the Xoft System at this facility.4
  • A retrospective analysis published in World Neurosurgery by Alexey Krivoshapkin, MD, PhD, et al. examined the repeat resection and the various methods of IORT for the treatment of malignant brain gliomas (MBGs), including high-energy linear accelerators and modern, integrated brachytherapy solutions using solid and balloon applicators.5 The findings from this review showed IORT with balloon applicators to be particularly promising.

 

Additional indications under investigation include prostate, pancreatic, colorectal and brain cancers.

For more information or to discuss participation in the Xoft Clinical Publication Support Program, please complete the form and we will contact you shortly.

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References:

1. WHO, IARC, Globocan Cancer Incidence and Mortality Worldwide in 2018. Accessed via https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.

2. Tamimi AF, Juweid M. Epidemiology and Outcome of Glioblastoma. In: De Vleeschouwer S, editor. Glioblastoma [Internet]. Brisbane (AU): Codon Publications; 2017 Sep 27. Chapter 8. Accessed via https://www.ncbi.nlm.nih.gov/books/NBK470003.

3. Pan E, Prados MD. Glioblastoma Multiforme and Anaplastic Astrocytoma. In: Kufe DW, Pollock RE, Weichselbaum RR, et al., editors. Holland-Frei Cancer Medicine. 6th edition. Hamilton (ON): BC Decker; 2003. Accessed via https://www.ncbi.nlm.nih.gov/books/NBK12526/.

4. University of Louisville. Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection. Accessed via https://clinicaltrials.gov/ct2/show/NCT04040400. ClinicalTrials.gov Identifier: NCT04040400.

5. Krivoshapkin A, et al. Repeat Resection and Intraoperative Radiotherapy for Malignant Gliomas of the Brain: A History and Review of Current Techniques. World Neurosurgery (2019) 132: 356-362. Accessed via https://doi.org/10.1016/j.wneu.2019.09.037.

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Brain IORT

Brain Tumor Treatment with Xoft IORT | Intraoperative Radiation Therapy

Additional indications under investigation include prostate, pancreatic, colorectal and brain cancers.

For more information or to discuss participation in the Xoft Clinical Publication Support Program, please complete the form and we will contact you shortly.

Contact Us