SAKK 41/16: Neoadjuvant treatment with Regorafenib and Capecitabine combined with radiotherapy in locally advanced rectal ca cer. A multicenter phase Ib trial (RECAP)
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abstract
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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.
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type of project
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clinical studies
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status
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ongoing - recruiting phase
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start of project
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2017
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end of project
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2019
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study design
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Phase 1b
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responsible person
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PD Dr. med. Markus Jörger
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