Cosmopolitan Trial will evaluate the single treatment of electron beam IORT, compared with weeks of standard radiation therapy
IntraOp Medical, a provider of portable electron-beam therapy, has enrolled first patient in to the Cosmopolitan Trial, a randomised study of radiation therapy for breast cancer.
Cosmopolitan Trial is aimed at evaluating single treatment electron-beam intraoperative radiation therapy (IORT), delivered during surgery compared to external beam radiation therapy for treating breast cancer.
Breast cancer is the most prevalent malignancy found in women, which makes them suffer from the side-effects related to the radiotherapy treatment, including fatigue which is persistent even after the their treatment is completed.
IntraOp CEO Derek T DeScioli said: “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.
“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.”
The Cosmopolitan Trial is aimed at demonstrating the superiority of electron IORT
Electron-beam IORT will replace 15 to 30 treatments of traditional radiotherapy, and is a superior de-escalation option for low risk breast cancer. The technology would be beneficial for patients who have an active lifestyle or travel long distances to receive their postoperative care.
The Cosmopolitan Trial is a multi-center clinical trial led by Heidelberg University professor Jürgen Debus in Germany as principal investigator.
The study is primarily aimed at demonstrating that electron IORT significantly increases the quality of life for patients, and reduces the costs for high quality care.
IntraOp is enagaged in developing electron therapy devices for the treatment of cancer. Its compact and mobile linear accelerators are designed to help oncologists deliver effective and precise radiation therapy at the point of care.
Heidelberg University department of radiation oncology medical director Jürgen Debus said: “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.”