Study to demonstrate the superiority of a single treatment of electron-beam IORT compared with weeks of standard radiation therapy
IntraOp Medical Corporation announced today the enrollment of the first patient in the Cosmopolitan Trial: A Prospective, randomized Phase II study of single treatment electron beam intraoperative radiation therapy (IORT) delivered during surgery compared to hypofractionated external beam radiation therapy which is delivered daily over the course of 3-4 weeks.
Breast cancer is the most frequent malignancy in women. For every 8 women, 1 is expected to be inflicted with breast cancer during her lifetime. Fortunately, with improvements in early detection and treatment, the prognosis for women diagnosed with early-stage breast cancer is quite favorable with 5-year survival rates near 100%. Yet many women suffer from side-effects related to their treatment. One of the most common side-effects of radiotherapy is fatigue, which is reported in up to 80% of cancer patients during treatment; and for 40%, such side effects may persist long after the completion of their treatment. This fatigue often significantly reduces quality of life due to functional impairment and psychological distress. Further, with rising healthcare costs, researchers are continuously investigating methods to de-escalate treatment not only to improve clinical results and quality of life for their patients but also to reduce the socio-economic burden for such care.
Single treatment electron-beam IORT, where a single dose of electron therapy delivered during surgery replaces 15 to 30 treatments of traditional radiation therapy delivered over a span of 3-6 weeks, is the ultimate form of de-escalation for low-risk breast cancer. Replacing weeks of treatment with a single dose of electron IORT may be particularly beneficial for patients who have an active lifestyle or have to travel long distances to receive their postoperative care. Fewer hospital visits not only reduces the burden on patients and their family members 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. Recently, based on the clinical evidence, the American Society for Radiation Oncology (ASTRO) affirmed the use of electron-beam IORT for suitable patients in its published treatment guidelines.
The Cosmopolitan Trial is a multi-center prospective clinical trial led by Principal Investigator Prof. Jürgen Debus of Heidelberg University in Germany. The primary objective of the study will be to demonstrate that a single treatment of electron IORT significantly increases the quality of life for patients, and thereby reduces the socioeconomic burden for providing high-quality care. Additionally, the study will employ the latest genetic assay technology to further evaluate the potential prognostic impact of tumor biology and gene expression-analysis in defining the best patients to receive such treatment. Secondary objectives include local control, toxicity, cosmesis, and survival.
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 employ electron IORT to de-escalate their treatment and significantly improve their quality of life while providing the same clinical effectiveness.
“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 employ electron IORT to de-escalate their treatment and significantly improve their quality of life while providing the same clinical effectiveness,” said Prof. Jürgen Debus, Medical Director for the Department of Radiation Oncology at Heidelberg University.
Founded over 600 years ago, Heidelberg University has a proud tradition of research and education in the field of medicine. Today, Heidelberg is recognized internationally as one of the world’s leading cancer research institutions.
“We are proud to be a sponsor for the Cosmopolitan Trial as it strengthens the clinical evidence supporting the role of electron beam IORT in treating breast cancer,” said Derek T. DeScioli, Chief Executive Officer of IntraOp Medical Corporation. “As the healthcare industry evolves to policies that reward value-based care, we expect increased adoption of our unique technology platform. Every breast cancer patient should have access to this modality and the option of having their surgery and radiation therapy conveniently completed at the same time.”