Denver CyberKnife obtains IRB approval as the only site in Colorado to participate in a phase IIII lung cancer trial comparing radiosurgery to surgery

Lone Tree, CO — April 15, 2010 — Denver CyberKnife radiation oncologist, Dr. Gregg Dickerson, and Cardiovascular Surgical Professionals thoracic surgeon, Dr. Richard Parker, have teamed up as the principal investigators for a clinical trial comparing two standard treatments for early-stage NSCLC (Non-Small Cell Lung Cancer), the most common form of lung cancer.

The STARS (Stereotactic Radiosurgery vs. Surgery) trial will compare the three-year survival rate of patients who undergo a lobectomy, a surgical procedure to remove the tumor, versus CyberKnife treatment, a unique stereotactic body radiotherapy (SBRT) technique that precisely tracks and focuses the radiation on the tumor.  SBRT is now an accepted treatment for medically inoperable patients with stage I NSCLC and patients with operable stage I lung cancer who are entered on clinical protocols. The purpose of this study is to conduct a phase III randomized prospective study to compare CyberKnife SBRT with surgery, the current standard of care for stage I operable NSCLC.

“SBRT for lung cancer has demonstrated excellent results for patients with medically inoperable lung cancer,” said Dr. Dickerson.  “In single institution, non-randomized studies for operable lung cancer, SBRT has shown to maintain at least equivalent results to surgery.  Patients will be the real beneficiaries from continued development of treatment alternatives for their conditions.”

NSCLC typically advances more slowly than small cell lung cancer. Smoking is the most common cause of lung cancers, including up to 85 percent of NSCLC cases. Denver CyberKnife is the only facility in Colorado to participate in the STARS clinical trial, which is led by M.D. Anderson Cancer Center in Houston, Texas and is enrolling patients in more than 20 centers around the world.

To qualify, prospective participants must be 18 years or older and have Stage I NSCLC. Additional diagnostic testing will be required to determine qualification. Once accepted into the study, participants will be randomly selected to receive surgery or radiation via the CyberKnife; both treatments are FDA-approved for lung cancer. Participants will be followed for three years after treatment, which will include follow-up consultations and additional treatment, if needed.

Dr. Gregg Dickerson, the medical director of Denver CyberKnife was recently quoted in an article by Michael Barbella in Medical Product Outsourcing’s September 2009 issue.  As a leader  in radiation oncology and, more specifically, radiosurgery, Dr. Dickerson was able to provide expert information to the author.

The following (in blue) is an excerpt from the article that features CyberKnife.  The full article can be accessed at: http://www.mpo-mag.com/articles/2009/09/embarking-on-a-fantastic-voyage

In 2001 (the same year Intuitive Surgical received approval for its da Vinci System), the FDA approved CyberKnife Radiosurgery for the treatment of tumors anywhere in the body. Since then, the company has received FDA approval for systems that enable doctors to track, detect and treat tumors in the lung, liver, pancreas and spine.

CyberKnife Radiosurgery is not actually a knife, but rather a radiation tool that can destroy tumors and lesions without surgery, pain, anesthesia or long recovery times. “CyberKnife [Radiosurgery] is able to accomplish an equivalent and perhaps superior treatment because it is not limited by the ability to remove critical tissues,” said Gregg A. Dickerson, M.D., F.A.C.R., and specialist in CyberKnife Radiosurgery at Denver CyberKnife, a radiation therapy center based in Colorado’s capital city. “We can radiate them. It’s a very surgical modality rather than a radiation tool. It’s more of a surgical instrument.”

CyberKnife Radiosurgery uses image guidance software to track and continually adjust treatment for any patient or tumor movement, allowing patients to breathe normally and relax comfortably during treatment. Before treatment, the patient undergoes imaging procedures (usually CT scans) to determine the size, shape and location of their tumor.

After the scanning is completed, doctors transfer the image data to the system’s workstation, where they identify the exact size, shape and location of the tumor to be treated. Doctors also identify the surrounding healthy tissue to be spared doses of radiation.

Once a treatment plan is created, the patient lies on a table for radiation treatments that last between 30 and 90 minutes. The treatment typically involves the administration of between 100 and 200 radiation beams delivered from different directions, each lasting 10 to 15 seconds. Before each beam of radiation is delivered, the CyberKnife Radiosurgery system simultaneously takes X-ray images and compares them to the original CT scan. This image-guided approach continually tracks, detects and corrects for any movement of the patient and tumor during the treatment process.

“CyberKnife Radiosurgery costs 30 percent to 50 percent less than a dose of radiation delivered the traditional way,” Dickerson noted. “It is a tremendous cost savings to the health care system. And patients love it. They don’t have complications afterward, they go on with their lives.”

Denver CyberKnife has also received FWA approval to continue through the IRB review process, a crucial step in the ability to participate in the groundbreaking STARS protocol.  This clinical study, sponsored by the MD Anderson Cancer Center in Houston, TX, is the premier radiosurgery study.  The intent is to compare lung radiosurgery to traditional lung surgery for patients with early-stage lung cancer.  The CyberKnife is the only device that MD Anderson deemed appropriate for use in this study.  Once finalized, Denver CyberKnife will be one of the few centers in the country to provide access to this important protocol.

Denver, CO — July 6, 2009 — Denver CyberKnife (www.DenverCK.com), the state-of-the-art treatment device for cancer and tumors throughout the body has aided the economic recovery in Denver through the creation of 8 new jobs.  Denver’s first CyberKnife was installed in late spring 2009 and was clinically operational in early June.  Although Denver CyberKnife is located in a brand new building and boasts the latest technology, the clinical staff is one of the most experienced in the world.  Dr. Gregg Dickerson, Steve Humphries, and Mark Post serve as the radiation oncologist, medical physicist, and radiation therapist, respectively; these professionals have over 15 years of combined CyberKnife experience, making Denver CyberKnife one of the most tenured centers in the world.

Mark Frank, Chief Administrator of Denver CyberKnife, is very happy to be able to be a part of providing the CyberKnife as a community resource.  “The CyberKnife System is the ideal radiosurgical tool given its flexibility and great range of clinical applications,” he stated. “In addition to proven effectiveness in treating tumors throughout the body, one of our most important benefits is patient comfort. By eliminating the use of a head or body frame, patient discomfort is significantly reduced. We are very pleased to bring this technology to our patient, as well as do our part to bolster the local economy.”

About Denver CyberKnife (www.DenverCK.com)

Denver CyberKnife is the only independent, free-standing radiation therapy center dedicated to treating patients with tumors using image-guided radiosurgery.  Denver CyberKnife treats the brain, spine, lung, prostate, pancreas, liver, head and neck, and other conditions throughout the body. Many patients are treated with the CyberKnife for conditions that have been deemed inoperable or from areas that have previously received the maximum level of radiation.  The range, accuracy and precision of the CyberKnife system can help target areas that may not be suitable for treatments with traditional surgery, radiation therapy or older radiosurgery systems, such as the gamma knife.  As an independent LLC, Denver CyberKnife is not affiliated with any particular hospital system, allowing it to provide the most unbiased care and treatment for the patients.  The center works with Medicare and with all major commercial insurance companies.

About the CyberKnife Robotic Radiosurgery System

The CyberKnife System is the world’s first and only commercially available intelligent robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. The CyberKnife System treats patients in single or staged (typically 2-5) sessions by precisely delivering multiple beams of radiation at a tumor while minimizing injury to surrounding healthy tissue. Image guidance and computer controlled robotics combine to continuously track, detect and correct for tumor and patient movement throughout the treatment. Because of this extreme precision and accuracy, no head or body frame is required. The CyberKnife System has attracted a new patient population to a physician’s practice and complements existing radiation therapy, IMRT or IGRT programs.

If have any questions, do not hesitate to contact us.

If you are a physician and would like to have a private tour, please contact us at (303) 396-1414 to set up a time that works for your schedule.

Denver, CO — June 22, 2009 — Denver CyberKnife (www.DenverCK.com) has announced that it is holding an open house on Thursday, June 25, 2009 from 4:00pm – 8:00pm in order to introduce the Denver community to its revolutionary CyberKnife® Robotic Radiosurgery System. An innovative radiosurgery device, the CyberKnife System is designed treat tumors anywhere in the body with sub-millimeter accuracy. It uses image guidance technology and computer controlled robotics to continuously track, detect and correct for tumor and patient movement throughout the treatment.

The event will include tours of the facility, as well as demonstrations of CyberKnife, for the press and public. Refreshments will be served.  “The CyberKnife System is the ideal radiosurgical tool given its flexibility and great range of clinical applications,” commented Mark Frank, Chief Administrator of Denver CyberKnife. “In addition to proven effectiveness in treating tumors in the lung, prostate, brain, spine and throughout the body, one of our most important benefits is patient comfort. By eliminating the use of a head or body frame, patient discomfort is significantly reduced. We are very pleased to bring this technology to our patients in the metro Denver area.”

About the CyberKnife Robotic Radiosurgery System
The CyberKnife System is the world’s first and only commercially available intelligent robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. The CyberKnife System treats patients in single or staged (typically 2-5) sessions by precisely delivering multiple beams of radiation at a tumor while minimizing injury to surrounding healthy tissue. Image guidance and computer controlled robotics combine to continuously track, detect and correct for tumor and patient movement throughout the treatment. Because of this extreme precision and accuracy, no head or body frame is required. The CyberKnife System has attracted a new patient population to a physician’s practice and complements existing radiation therapy, IMRT or IGRT programs.

About Denver CyberKnife (www.DenverCK.com)
Denver CyberKnife is a free-standing radiation therapy Center dedicated to treating patients with tumors using image-guided radiosurgery.  We treat the brain, spine, lung, prostate, pancreas, liver, head and neck, and other conditions throughout the body using the CyberKnife. Many of our patients are treated with the CyberKnife for conditions that have been deemed inoperable or from areas that have previously received the maximum level of radiation.  The range, accuracy and precision of the CyberKnife system can help target areas that may not be suitable for treatments with traditional surgery, radiation therapy or older radiosurgery systems, such as the gamma knife.  As an independent LLC, we are not affiliated with any particular hospital system.  This allows us to provide the most unbiased care and treatment for our patients.  We work with Medicare and with all major commercial insurance companies.