Regorafenib assessment in refractory advanced colorectal cancer: RegARd-C study protocol

BMJ Open
Alain HendliszPatrick Flamen

Abstract

Regorafenib was recently approved for patients with pretreated advanced colorectal cancer (aCRC), despite a moderate improvement of the patients' outcome, and significant toxicities. Based on previous studies showing that early fluorodeoxyglucose-positron emission tomography (FDG-PET)-based metabolic response assessment (MRA) might adequately select patients unlikely to benefit from treatment, the RegARd-C trial uses early MRA to identify likely non-responders to regorafenib in a population of patients with aCRC and guide a comprehensive evaluation of genomic and epigenetic determinants of resistance to treatment. RegARd-C is a multicentric prospective study. Its primary objective is to identify non-benefitters from regorafenib given at 160 mg/day, 3 weeks out of 4 in a population of patients with pretreated aCRC. Baseline PET is repeated at day 14 of the first treatment course. MRA is blinded for the investigators. Overall survival (OS) is the primary end point and will be correlated with metabolic parameters and (epi)genetic alterations assessed from tumour and serial blood samples. A target sample size of 105 evaluable patients (70 as derivation set and 35 as validation set), is considered as sufficient to validate an expect...Continue Reading

References

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Citations

Apr 14, 2016·European Journal of Nuclear Medicine and Molecular Imaging·Erwin WoffPatrick Flamen
Nov 17, 2020·Therapeutic Advances in Medical Oncology·Fotios LoupakisTanios Bekaii-Saab
Jul 1, 2018·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Erwin WoffPatrick Flamen
Aug 19, 2021·Clinical Colorectal Cancer·Caroline VandeputteFrancesco Sclafani

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Methods Mentioned

BETA
biopsies
methylation
biopsy

Software Mentioned

EXCEPT
SoMore
CORRECT
RegARd

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