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Assessment of performance status (PS) is an essential part of inclusion criteria in oncology clinical trials. It correlates with the major study outcomes. Among limitations of PS assessment is lack of well-defined criteria which may lead to difference in interpretation. We present 3 cases of misinterpretation of patients' clinical condition that lead to different PS assessment. In 2 cases activity of patients was limited due to factors other than oncology disease, recent surgery and concomitant medical condition (obesity). Such situations as presence of concomitant factors that have a potential to limit patient's ability to perform working or daily living activities, should be carefully considered while assessing PS.

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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.