The FOLICOLOR trial aims to evaluate whether a liquid biopsy-guided follow-up strategy can improve outcomes in patients with unresectable, metastatic colorectal cancer (mCRC) receiving first-line systemic treatment. The approach uses NPY methylation-based circulating tumor DNA (ctDNA) analysis from blood samples to monitor treatment response and guide clinical decision-making. Eligible patients are adults diagnosed with unresectable, metastatic colorectal cancer who are starting first-line treatment. The primary goal is to demonstrate a clinically meaningful benefit, particularly in terms of quality of life (QoL) and reduction of treatment-related toxicity, by allowing earlier and more personalized therapeutic adjustments based on liquid biopsy findings.
FOLICOLOR is a prospective, randomized, open-label, multicentric phase 3 study evaluating the clinical value of ctDNA-based liquid biopsy in the follow-up of patients receiving first-line therapy for metastatic colorectal cancer. Patients with confirmed NPY methylation-based ctDNA positivity on an initial liquid biopsy sample will be randomized into two study arms: * Control arm (CT arm): Treatment decisions are guided by radiographic evaluation using conventional CT scans. * Study arm (LB arm): Treatment decisions are guided by serial liquid biopsy results. All patients are followed per study protocol for 18 months from the time of inclusion. Primary Objective: To determine whether a liquid biopsy-guided follow-up strategy preserves quality of life (QoL) for longer, by enabling earlier detection of disease progression and more timely therapeutic adjustments, thereby reducing exposure to ineffective treatment and associated toxicity. Secondary Objectives: * To evaluate whether liquid biopsy allows earlier detection of progressive disease compared to conventional CT imaging (per RECIST 1.1 criteria). * To assess time to progression and progression-free survival (PFS) in both the LB arm and CT arm, with progression defined as progressive disease (PD) per RECIST 1.1. * To evaluate the difference in 3-year overall survival (OS) between both study arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
150
The LB arm is the intervention group where the evaluation of therapy is guided by Liquid Biopsy results
AZ Sint Maarten
Mechelen, Antwerpen, Belgium
RECRUITINGAZ Klina
Brasschaat, Antwerp, Belgium
RECRUITINGUniversity Hospital Antwerp
Edegem, Antwerp, Belgium
RECRUITINGSint-Augustinus (ZAS)
Wilrijk, Antwerp, Belgium
RECRUITINGGrand Hopital de Charleroi
Charleroi, Henegouwen, Belgium
RECRUITINGAZ Maria Middelares, Ghent
Ghent, Oost-Vlaanderen, Belgium
RECRUITINGVitaz
Sint-Niklaas, Oost-Vlaanderen, Belgium
RECRUITINGAZ Sint Lucas, Brugge
Bruges, West-Vlaanderen, Belgium
RECRUITINGAZ Groeninge, Kortrijk
Kortrijk, West-Vlaanderen, Belgium
RECRUITINGTime to Deterioration (TTD) in Quality of Life (QoL)
The primary objective of this study is to determine whether the technique of monitoring patients with liquid biopsies can ensure that patients experience a slower decline in their quality of life (and can therefore maintain a good quality of life for longer). This will be evaluated through the difference in time to deterioration (TTD) in Quality of Life (QoL) between patients in which follow-up is done based on the results of LBs (LB-arm) in comparison to the patients in which follow-up is done based on the conventional follow-up techniques (CT-arm). TTD is defined as time from randomization to the first decrease from baseline on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ-CR29) summary score by at least 10 percent.
Time frame: 18 months
Progression Free Survival (PFS)
To compare progresion free survival between the LB-arm and the CT-arm (progression is defined as PD on CT scan according to RECIST 1.1 criteria).
Time frame: 18 months
3 year overall survival
To evaluate the 3-year overall survival difference between both study arms.
Time frame: 3 year
Earlier detection of progressive disease with liquid biospies
The proportion of patients in which progressive disease can be detected earlier based on the results of liquid biopsies in comparison to conventional CT scans (with RECIST 1.1 measurements).
Time frame: 18 months
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