Accuray, a developer in the field of radiosurgery, has partnered with The University of Texas M. D. Anderson Cancer Center in Houston to launch a prospective clinical study to compare Cyberknife radiosurgery to traditional surgery in early-stage operable lung cancer patients.
Currently, Accuray and its partners at M.D. Anderson have begun enrollment for their trial. They expect to enroll approximately 1,200 candidates, 600 in each arm, who will be randomly assigned to either Cyberknife radiosurgery treatment or surgical lobectomy. The company expects that the trial will take place in about 40 facilities, which have Cyberknife capabilities in Europe, Asia and the United States.
Not all of the sites have currently been solidified, and the Sunnyvale, Calif.-based Accuray hopes to begin accruing participants this spring.
In the United States, 173,000 people are diagnosed with lung cancer each year, and of those cases 95 percent will die, based on the current mortality rates. About 70-80 percent are diagnosed with late-stage lung cancer, and those patients are often dealing with metastases of the disease to the brain, or elsewhere, in addition to having to survive their local disease.
Lung screening is going to change how patients are diagnosed; much like how the PSA test altered prostate cancer screening, and how mammography changed the diagnosis of breast cancer, according to Eric Lindquist, senior vice president and chief marketing officer at Accuray.
Lindquist said that the patients who are diagnosed early have a higher chance of cure, but it also means that patients have a wider variety of treatment options. He listed the potential treatments of patients with early-stage lung cancer: surgery, external beam radiation and Cyberknife. The benefits of the latter technique, according to Lindquist, are the ability to deliver high doses of radiation, to lock on and track the movement of the tumor while emitting radiation directly to the tumor itself, while minimizing radiation to the surrounding healthy tissue. He also said that the non-invasive Cyberknife requires far less recovery time than traditional surgery.
Omar Dawood, MD, vice president of clinical development at Accuray, said that although the trial is solely funded by Accuray, it was initiated by investigators. Jack A. Roth, MD, department of thoracic and cardiovascular surgery, and colleagues at M.D. Anderson, as well as John J. Kresl, MD, at St. Joseph's Hospital & Barrow Neurological Institute in Phoenix, proposed the comparative trial to Accuray, he said.
For the Phase III trial, Dawood said that the study will include patients who have undergone a biopsy to ascertain that they have non-small cell lung cancer. The participants must be in the very early stages of lung cancer; either Stage IA (tumor must be 4cm or less) or Stage IB. The final eligibility criterion is that every patient has to be a good operable candidate, Dawood said.
Also, he said no participant will be treated by both techniques, and still be eligible; and no chemotherapy or any other pharmaceutical therapy will accompany the procedures.
Finally, Dawood said that the primary endpoint of the trial was overall survival over a follow-up of up to five years. The secondary endpoints are: disease-specific survival, because they are good operable candidates, they should not have other complications that could lead to death; local control of the tumor in the treated area; and overall toxicity.
Lindquist said that the company hopes that the trial will demonstrate “that the Cyberknife is as good as, or better than surgery, in treating early-stage lung cancer patients.”