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
86 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
Researchers are evaluating a follow-up strategy using liquid biopsy to guide treatment decisions in adults with unresectable, metastatic colorectal cancer starting first-line systemic therapy. This phase 3 study compares the use of NPY methylation-based circulating tumor DNA (ctDNA) analysis from blood samples against conventional CT scans to monitor treatment response. The goal is to improve quality of life by enabling earlier therapeutic adjustments and reducing exposure to ineffective treatments and related toxicity. Participants with positive ctDNA results will be randomly assigned to one of two groups: a control group where treatment decisions follow standard radiographic evaluations and an intervention group where decisions are guided by serial liquid biopsy results. All participants will be followed for 18 months to assess outcomes, with a focus on quality of life and treatment toxicity. Secondary goals include evaluating earlier detection of disease progression, progression-free survival, and overall survival at three years. During the study, participants will undergo regular blood tests for liquid biopsy or CT scans depending on their group, along with routine clinical assessments. Researchers will measure time to deterioration in quality of life over 18 months as the primary outcome. Additional measures include progression-free survival and overall survival over three years. The study also monitors the timing of detecting disease progression and treatment adjustments. Safety and treatment effects will be closely observed throughout the follow-up period.
CONDITIONS
Brief Title
FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Man or woman 18 years of age or older at the time of informed consent
- ECOG performance status of 0-2
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with unresectable metastatic disease
- At least one measurable lesion of 10 mm or more on CT or MRI scan
- All disease sites evaluated within 28 days prior to randomization
- Adequate hematology, renal, hepatic, and coagulation function as determined by physician
- Adequate blood results for treatment as determined by physician
- Starting first line systemic treatment for metastatic colorectal cancer
You will not qualify if you...
- History of prior or current central nervous system metastases
- History of other malignancies except those treated with curative intent and no active disease for 3 or more years
- Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ without evidence of disease
- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- Prior chemotherapy or systemic anticancer therapy for metastatic colorectal cancer
- Prior adjuvant chemotherapy or systemic therapy for colorectal cancer within 6 months before randomization, except fluoropyrimidine used only for radiosensitization
- Radiotherapy within 14 days prior to randomization or unresolved radiotherapy-related toxicities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months from the time of inclusion
Participants receive first-line systemic treatment for metastatic colorectal cancer and are randomized to follow-up guided either by liquid biopsy results or conventional CT scans to evaluate therapy response.
Regular visits for treatment and monitoring per study protocol
Duration - Up to 18 months from inclusion
Participants are followed for ongoing monitoring of quality of life, disease progression, and survival outcomes after treatment decisions guided by either liquid biopsy or CT imaging.
Scheduled visits for assessments according to study protocol
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
A
Ayla Wyninckx
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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