Actively Recruiting
FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients
Led by University Hospital, Antwerp · Updated on 2026-04-30
150
Participants Needed
9
Research Sites
519 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Antwerp
Lead Sponsor
K
Kom Op Tegen Kanker
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years or older
- ECOG performance status 0 to 2
- Confirmed adenocarcinoma of colon or rectum with unresectable metastatic disease
- At least one measurable lesion of 10 mm or larger on CT or MRI (not from previously irradiated area unless progression occurred)
- All disease sites evaluated within 28 days before randomization
- Adequate blood, kidney, liver, and coagulation function as judged by doctor
- Starting first-line treatment for metastatic colorectal cancer
You will not qualify if you...
- History of central nervous system metastases
- History of other cancers unless treated with curative intent and no active disease for at least 3 years
- Adequately treated non-melanoma skin cancer or lentigo maligna without active disease
- Adequately treated cervical carcinoma in situ without active disease
- Prostatic intraepithelial neoplasia without prostate cancer
- Prior chemotherapy or systemic anticancer therapy for metastatic colorectal cancer, including bevacizumab or anti-EGFR therapies
- Adjuvant chemotherapy or systemic therapy for colorectal cancer within 6 months before randomization, except fluoropyrimidine for radiosensitization
- Radiotherapy within 14 days before randomization without full recovery from side effects
AI-Screening
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Trial Site Locations
Total: 9 locations
1
AZ Sint Maarten
Mechelen, Antwerpen, Belgium, 2800
Actively Recruiting
2
AZ Klina
Brasschaat, Antwerp, Belgium, 2930
Actively Recruiting
3
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
4
Sint-Augustinus (ZAS)
Wilrijk, Antwerp, Belgium, 2610
Actively Recruiting
5
Grand Hopital de Charleroi
Charleroi, Henegouwen, Belgium, 6020
Actively Recruiting
6
AZ Maria Middelares, Ghent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
7
Vitaz
Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
Actively Recruiting
8
AZ Sint Lucas, Brugge
Bruges, West-Vlaanderen, Belgium, 8000
Actively Recruiting
9
AZ Groeninge, Kortrijk
Kortrijk, West-Vlaanderen, Belgium, 8500
Actively Recruiting
Research Team
S
Sanne Wouters
CONTACT
A
Ayla Wyninckx
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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