Researchers at Indiana University School of Medicine reported that the results of the extracranial stereotactic radioablation Phase I study for non-small cell lung cancer led the group to continue with the second phase of the clinical trial.

The initial phase tested the toxicity of increasingly large doses of radiation precisely focused on the lung tumor. Enrollment in the trial began in February 2000 and 37 patients participated. Researchers report that surprisingly high doses of radiation were tolerated and 87 percent of patients had positive tumor response. Only six patients had local recurrence of cancer, all treated at the lower dose levels used at the onset of the trial. Local recurrence has not been observed to date at the highest levels.

Patients enrolled in the Phase I study had to have stage I non-small cell lung cancer that was medically inoperable because of extenuating health problems. Non-small cell lung cancer accounts for 80 percent of all lung cancers and is the leading cause of cancer-related fatalities in the United States. In the U.S., 170,000 new cases of lung cancer are diagnosed each year and there are 157,000 deaths caused by the disease.

"Lung cancer patients frequently have other health problems such as emphysema or heart disease that makes them a bad risk for the standard surgical therapy for their disease," said Robert Timmerman, M.D., associate professor of radiation oncology and the principal author of the article.

Using a painless, minimally invasive therapy, Timmerman and his IU colleagues used 3-D imaging and stereotactic body mapping to precisely target the tumor down to a millimeter so that healthy tissue was spared the intensity of the photon radiation. Stereotactic mapping utilizes a specially designed, lightweigh
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Contact: Mary Hardin
mhardin@iupui.edu
317-274-7722
Indiana University
10-Nov-2003