Trial Compares Sbrt To Surgery For Early-Stage Lung Cancer

A new phase III clinical trial at the Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine is designed to determine the optimal treatment for patients with early- stage non-small cell lung cancer (NSCLC) who are at high risk for surgery.

The randomized trial compares three treatments of stereotactic body radiation therapy (SBRT) to sublobar resection with or without intra- operative brachytherapy using iodine I-125.  To be eligible, patients must have clinical stage 1A or selected 1B NSCLC, and poor lung function, which increases the risk of undergoing surgical resection of the tumor.

An estimated 420 patients will be enrolled in the trial, sponsored by the National Cancer Institute and coordinated through the American College of Surgeons Oncology Group (ACOSOG) and the Radiation Therapy Oncology Group (RTOG).

“Our hope is that doctors and patients will embrace this cutting-edge trial so we can clarify the optimal treatment for this group of higher- risk patients,” says study co-investigator Bryan Meyers, MD, chief of the Section of Thoracic Surgery and chair of the ACOSOG Thoracic Disease Site Committee. “For very frail patients, we have SBRT. For fit patients, surgery still dominates. This trial looks at people on the cusp for whom we don’t have certainty.”

For decades, the standard treatment for early- stage non-small cell lung cancer has been surgery, but the procedure can be difficult for patients with poor lung function, such as those with emphysema and pulmonary hypertension.

SBRT is a specialized type of external beam radiation therapy that pinpoints high doses of radiation directly on the cancer in a shorter amount of time than traditional treatments.

“We have been evaluating SBRT for lung cancer since 2004 and have one of the largest U.S. experiences,” says study co-investigator Jeffrey Bradley, MD, professor of radiation oncology and chair of RTOG’s lung cancer committee. “In an earlier trial of technology in very frail NSCLC patients who were not eligible for surgery, we and others showed that more than half of patients who received stereotactic body radiation therapy survived for three years after their diagnosis.”

For the current study, researchers will compare overall survival and disease-free survival in the two treatment arms. They will also evaluate patients’ quality of life.