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Aim: To define the inclusion/exclusion status of patients with brain metastasis in phase-III clinical trials and the effect of systemic therapies in metastatic renal cell cancer patients with brain metastasis. Methods: "kidney neoplasms"[MeSH Terms] OR ("kidney"[All Fields] AND "neoplasms"[All Fields]) OR "kidney neoplasms"[All Fields] OR ("kidney"[All Fields] AND "cancer"[All Fields]) OR "kidney cancer"[All Fields] AND "brain metastasis" were used for searching "PubMed" electronic database and "clinicaltrials.gov" website. Results: Five of 19 landmark phase-III clinical trials included patients with stable or asymptomatic brain metastasis and there was no data about outcomes of brain metastasis. The effect of systemic therapy on prevention of brain metastasis in renal cell cancer was evaluated in four studies. Two studies showed that the incidence of brain metastasis decreased, while the other two studies showed no effect of antiangiogenic agents on the prevention of brain metastasis in patients with renal cell cancer. There were 10 trials regarding systemic therapy of renal cell cancer brain metastasis. The overall response rate improved through a combination of targeted therapies and local treatment. The results of the trials studying the effect of tyrosine kinase inhibitors without local treatment were controversial. None of the ongoing clinical trials included patients with active brain metastasis. Conclusion: In metastatic renal cell cancer patients with brain metastasis, the overall response rate improved with the combination of targeted agents and local treatment. Further trials are needed to evaluate the effect of systemic treatment on the prevention or treatment of brain metastasis in patients with renal cell cancer. [ABSTRACT FROM AUTHOR]