Detection of progressive disease by neuropeptide Y (NPY) methylation in liquid biopsies in patients with RAS and BRAF wild-type, unresectable, metastatic colorectal cancer receiving first-line treatment FOLFOX/FOLFIRI and panitumumab.
Prospective, multicentric interventional study to optimize the cutoff value of NPY methylation in liquid biopsies in metastatic colorectal cancer patients treated with first-line FOLFOX/FOLFIRI and panitumumab. Inclusion is possible after histologically or cytologically proven colorectal adenocarcinoma with metastatic lesions according to RECIST 1.1 at the start of first-line treatment using FOLFOX/FOLFIRI and panitumumab. Patient must have a proven RAS and BRAF wild-type tumor. Patients will be followed by study protocol up to and including the first CT scan following the last liquid biopsies taken, or when a follow-up period of 11 months is reached, until death, until metastasectomy, until lost to follow-up or until (consent) withdrawal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
Biweekly liquid biopsy sampling to measure circulating tumor DNA (ctDNA) level up to and including 9 months after start first-line therapy.
AZ Klina
Brasschaat, Belgium
RECRUITINGAntwerp University Hospital (UZA)
Edegem, Belgium
RECRUITINGAZ Maria Middelares
Ghent, Belgium
RECRUITINGOptimize cutoff value
Optimization of the cutoff value for NPY methylation in liquid biopsies (ctDNA) in metastatic colorectal cancer patients receiving first-line FOLFOX/FOLFIRI and panitumumab to discriminate between progressive and non-progressive disease as determined by CT scans based on RECIST criteria 1.1. To this end, a Receiver Operating Characteristic (ROC) curve will be developed with data of this study.
Time frame: Start cycle 1 of first-line FOLFOX/FOLFIRI and panitumumab therapy until the day on which the first CT scan is performed following the liquid biopsies taken 9 months after the start of first-line therapy, or when 11 months of follow-up is reached.
Determine progression free and 9-month survival
To determine the progression free and 9-month survival of RAS and BRAF wild-type metastatic colorectal cancer patients. The progression free survival is defined as time from inclusion to the date of first disease progression per RECIST 1.1 criteria, or death. The 9-month survival will be determined as percentage surviving at 9 months after the start of first-line therapy.
Time frame: Start cycle 1 of first-line FOLFOX/FOLFIRI and panitumumab therapy until the day on which the first CT scan is performed following the liquid biopsies taken 9 months after the start of first-line therapy, or when 11 months of follow-up is reached.
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AZ Groeninge
Kortrijk, Belgium
RECRUITINGAZ Nikolaas
Sint-Niklaas, Belgium
RECRUITINGGZA
Wilrijk, Belgium
RECRUITING