A phase 1 study is enrolling patients in a clinical trial of a minimally invasive treatment for patients living with cancer that has spread to the spine. The treatment is designed to help relieve pain, heal spinal fractures, and prevent new fractures.
The spine is the most common site of bone metastases. A tumor can weaken a vertebra, causing it to collapse on itself and resulting in severe pain and impaired mobility.
The new study, which has opened at Loyola University Medical Center in Maywood, Illinois, is testing a new combination treatment that delivers radiation directly to the tumor and increases support of the spine.
The multidisciplinary group of physicians performing this treatment at Loyola includes interventional radiologists, orthopaedic surgeons, and radiation oncologists.
The first patient to undergo the combination treatment has metastatic lung cancer that has spread to his spine. Physicians performed the procedure on two vertebral levels in the middle of the back (T10 and T12). “The surgery alleviated the pain quite a bit,” the patient said.
In the procedure, interventional radiologist Angelo Malamis, MD, first made a small incision in the spine vertebra and inserted a spinal applicator needle to deliver radiation directly to the tumor.
Once the applicator is in place, a team from Radiation Oncology, led by William Small, Jr, MD, confirms proper placement and the radiation is delivered (intraoperative radiotherapy) over the course of a few minutes. In contrast to standard external beam radiation, the more precise intraoperative radiotherapy can deliver a higher dose of radiation, while minimizing the adverse effects to normal tissue.
The second half of the operation is a procedure called a kyphoplasty. It is completed by an interventional radiologist or orthopaedic surgeon. A needle cannula is inserted through the incision. A balloon at the tip of the cannula is inflated to increase the height of the collapsed vertebra, and a cement-like material is injected into the radiated area to help stabilize the spine.
The purpose of the phase 1 study is to learn about both the good and bad effects of combining intraoperative radiotherapy and kyphoplasty. Researchers will compare the pain levels and use of pain medications before and after the procedure. They also will monitor quality-of-life issues, the effect of the procedure on the tumor, and any complications.
The study is titled “Combining Intraoperative Radiotherapy with Kyphoplasty for Treatment of Spinal Metastases (Kypho-IORT)”. It is sponsored by the departments of Radiation Oncology and Radiology of Loyola University Chicago Stritch School of Medicine. The principal investigator is Small, who is chair of the Department of Radiation Oncology. Co-investigators are Malamis; Abhishek Solanki, MD; Karan Shah, MD; and Janushi Dalal, MD.
To qualify for the trial, a patient must meet several criteria, including age 50 years or older and having metastatic cancer that has spread from a solid tumor to the spine.