Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Disease Progression

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Panitumumab

Chemotherapeutic agents will be given as an intravenous infusion at a dose and interval consistent with standard institutional practice.

Biweekly liquid biopsy sampling to measure circulating tumor DNA (ctDNA) level up to and including 9 months after start first-line therapy.

Liquid biopsy sampling

Silke Raats

Katleen Janssens, MD

Laura Tanasale

Sofie Herman

Wim Demey, MD

Marc Peeters, MD

Laura Van Damme

Nina Van Heddegem

Els Monsaert, MD

Emma Callewaert

Fien Verplancke

Philippe Vergauwe, MD

Roos Haeck

Helga Vunic

Koen Gorleer, MD

Isabelle Maurissen, MD

Marc Peeters, MD, PhD

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.

lead-in FOLICOLOR Trial: Following Therapy Response Through Liquid Biopsy in Metastatic Colorectal Cancer Patients

Detection of Progressive Disease in Metastatic Colorectal Cancer Patients by NPY Methylation in Liquid Biopsies

To compare the use of NPY methylated ctDNA and carcinoembryonic antigen (CEA) to predict progressive disease.

Further exploration of ctDNA in liquid biopsies and searching for novel biomarkers.

To assess the quality of life and the patient experience in the patient population with regard to the use of liquid biopsies for follow-up through questionnaires. This will include, but will not be limited to the following: burden of extra blood samples (extra blood samples during routine blood test), burden of CT scan with intravenous contrast, confidence in liquid biopsy guided therapy (ctDNA analysis) compared to CT scan guided therapy and preference between extra blood sample and CT scan (taking into account: burden, pain, time in the hospital, extra travel time to the hospital, confidence in technique...).

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.

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.

Amgen

University Hospital, Antwerp

Spots Global Cancer Trial Database for liquid biopsy sampling