Evaluation of Regorafenib in patients with a metastatic colorectal cancer resistant to all other therapies

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-005655-16

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Extrait

To identify in a population of patients bearing advanced, refractory colorectal cancers, those who draw no benefit from treatment with regorafenib. There is no specific hypothesis underlying sample size and the study is therefore to be seen as exploratory. Overall Survival (OS) will be used as primary endpoint. Covariates that will be analyzed in relationship with OS will be metabolic parameters obtained at baseline and very early following treatment initiation as well as genetic, epigenetic and molecular aberrations (before and after treatment) assessed from tumor biopsies and blood samples, in addition to known clinical and pathological factors. The molecular aberrations will be investigated using gene expression profiling, RNA and exome sequencing, and methylation profiling of the tumor biopsies and repeated blood samples taken during therapy.


Critère d'inclusion

  • Advanced refractory colorectal cancer

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