News | Radiation Therapy | April 22, 2020

First Patient Enrolled in Cosmopolitan Trial for Breast Cancer

Study to demonstrate the superiority of a single treatment of electron beam IORT compared with weeks of standard radiation therapy

Study to demonstrate the superiority of a single treatment of electron beam IORT compared with weeks of standard radiation therapy

April 22, 2020 — IntraOp Medical Corporation announced the first patient enrolled in the Cosmopolitan Trial: A randomized study of single treatment electron-beam intraoperative radiation therapy (IORT) delivered during surgery compared to external beam radiation therapy which is delivered over 3-4 weeks.

Breast cancer is the most frequent malignancy in women. For every 8 women, 1 will be inflicted with breast cancer during her lifetime. Many women suffer from side-effects related to their treatment. One of the most common side-effects of radiotherapy is fatigue, which, for 40 percent of patients, persists long after completing their treatment. Further, with rising healthcare costs, researchers are continuously investigating methods to de-escalate treatment not only to improve clinical results for their patients but also to reduce the socio-economic burden for such care.

Electron-beam IORT, which replaces 15 to 30 treatments of traditional radiotherapy, is the ultimate form of de-escalation for low risk breast cancer. Electron IORT may be particularly beneficial for patients who have an active lifestyle or travel long distances to receive their postoperative care. Fewer hospital visits not only reduces the burden on patients and their family but also hospital staff and resources—a topic at the forefront for all healthcare executives and government officials in the wake of the current COVID-19 pandemic.

The Cosmopolitan Trial is a multi-center trial led by Principal Investigator Prof. Jürgen Debus of Heidelberg University in Germany. The primary objective of the study is to demonstrate that electron IORT significantly increases the quality of life for patients; thereby reducing the socioeconomic burden for providing high quality care.

"Breast cancer remains one of the most common cancers inflicting women. The clinical evidence indicates that many breast cancer patients are being over treated; and we see a significant opportunity to employ electron IORT to de-escalate their treatment and significantly improve their quality of life while providing the same clinical effectiveness," said Debus, Medical Director for the Department of Radiation Oncology at Heidelberg University.

"We are proud to sponsor the Cosmopolitan Trial as it strengthens the clinical evidence supporting the role of electron-beam IORT in treating breast cancer," said Derek T. DeScioli, CEO of IntraOp. "As the healthcare industry evolves to value-based care, we expect increased adoption of our technology. Every breast cancer patient should have the option to having their surgery and radiotherapy conveniently completed at the same time."

For more information: https://intraop.com/

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