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Kurzbeschreibung/Zielsetzung

Despite treatment of locally advanced rectal cancer re-lapses are frequent. Several attempts to improve these results with therapy intensification have shown modest effect on disease free survival (DFS) and overall survival (OS). Recent studies with addition of sorafenib and cediranib revealed promising effect on tumor response with acceptable toxicity. Regorafenib is a multi tyrosine kinase inhibitor (TKI) with a broad mechanism of action. Therefore this trial investigates if similar results can be achieved as with sorafenib or cediranib. The objective of the dose esca-lation part is to determinate safety, tolerability and the rec-ommended dose. The objective of the expansion cohort is to assess the efficacy and to further characterize safety and tolerability of the therapy.