Enrollment of Patients with Brain Metastases in Clinical Trials

Abstract

The brain is a common site of tumor metastases, however patients with brain metastases are frequently either excluded from enrollment in clinical trials, or may be enrolled with limitations -clinically stable and/or previously treated. However, there is still no universally accepted definition of what to consider adequately treated and stable brain metastasis, which in turn, may lead to an excessively conservative approach to enroll such patients. During design of a study protocol that allows enrollment of patients with previously treated brain metastases, it is imperative to consider specifying the allowed previous treatment(s). We also recommend potential patients with a history of brain metastases to have a brain MRI as close to the planned start of chemotherapy, as possible, and if new lesions are identified, to treat them as appropriate before enrollment in the trial; this may give patients a chance to enter the trial, if the results of treatment are beneficial.