Intraop Medical, Inc. announces that Felipe Calvo, Director of Radiation
Oncology at the University Hospital Gregario Maranon in Madrid Spain, and Dr. Ignacio Azinovic of Hospital San Jaime in Torrevieja, Spain,
have agreed to be the co-Principal Investigators of a new intraoperative radiotherapy (“IORT”) lung protocol study for Europe.
The protocol is based on a pilot study of about 100 patients treated with IORT at the University of Navarre in Pamplona, Spain. In this pilot study,
patients were transported from the surgical theater to the radiation department in the middle of the surgery to give the IORT treatment using a
conventional electron linear accelerator. After the IORT treatment, the patients were transported back to the operating room for the completion
of the surgery. This pilot study showed significant improvement in both local control and survival (about 40% five year survival) compared to
conventional treatment for advanced lung cancer (about 15% five year survival). Dr. Calvo was Director of Radiation Oncology and Dr. Ignacio
Azinovic was a senior radiation oncologist at the University of Navarre during this pilot study.
Smaller IORT studies in the U.S. and China showed similar positive results, but because of the difficulty of delivering IORT for lung cancer patients
through patient transportation, it has been difficult to establish IORT as an important component of advanced lung cancer treatment. This new study
is designed to determine the role of IORT in advanced lung cancer treatment. In addition to Hospital Gregorio Maranon and Hospital San Jaime,
several European centers with dedicated IORT treatment systems are expected to participate in the protocol.
Dr. Calvo, past President of the International Society of Intraoperative Radiation Therapy, is one of the world’s leading specialists in IORT
treatments and is the author or co-author of numerous books and articles on the use of IORT in the treatment of cancer patients. He has recently
co-authored a chapter on the use of IORT for treating lung cancer, summarizing much of the IORT results obtained at Pamplona. Dr. Azinovic is
a well-known radiation oncologist with a strong background in IORT treatment. He is the author or co-author of numerous articles on IORT,
including co-authoring definitive chapters on the use of IORT in the treatment of soft tissue sarcomas, recurrent colorectal cancer, and lung cancer
in “Intraoperative Irradiation---Techniques and Results”.
“We are fortunate to have two such prominent practitioners and researchers head this important study”, says Dr. Donald Goer, President and CEO
of Intraop Medical, Inc. “We feel it is important to have this European study in addition to the U.S. IORT lung study, because the chemotherapy
used in Europe for this disease is different than that used in the U.S. Doing studies in both places should demonstrate whether the IORT portion
of the treatment is effective in this disease.
“Our earlier work using IORT at the University of Navarre showed that IORT could be a useful component in the treatment of some advanced
lung cancer patients”, said Dr. Felipe Calvo. “It is hoped that a carefully conducted trial will determine the role of IORT in the treatment of this
disease. We expect that several other centers with IORT capability will elect to join the study.”
“Lung cancer is one of the sites of interest for IORT at Hospital San Jaime, says Dr. Ignacio Azinovic. “We are fortunate that several members
of our oncology team already have familiarity with the use of IORT for lung cancer from their previous experience at the University of Navarre.
With other European centers interested in this lung protocol, we hope to be able to accrue patients needed in this study relatively quickly.
The study will be funded in part by Intraop Medical, Inc.
