Clinical Trials in Belgium / NCT07558083
Recruiting Phase 3

FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients

NCT07558083 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 3
Started
2021-08-16
Last updated
2026-04-30

Condition(s) studied

Advanced Colorectal Cancer

Investigational drug(s) / intervention(s)

Evaluation therapy through Liquid Biopsy

Evaluation therapy through Liquid Biopsy: The LB arm is the intervention group where the evaluation of therapy is guided by Liquid Biopsy results

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Man or woman ≥ 18 years of age at the time the informed consent is obtained * ECOG performance status of 0-2 * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic (M1) disease * There should be at least 1 uni-dimensionally measurable (min. 10mm) using conventional crosssectional imaging techniques (CT or MRI scan). Lesion must not be chosen from a previously irradiated field, unlessnthere has been documented disease progression in that field after irradiation and prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization * Adequate hematology, renal, hepatic and coagulation function (at treating physician's discretion) * Adequate blood results for treatment (at treating physician's discretion) * Starting a first line treatment Exclusion Criteria: * History of prior or concurrent central nervous system metastases * History of other malignancy, except: Malignancy treated with curative intent and with no known active disease present for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician. Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease. Adequately treated cervical carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cancer * Prior chemotherapy or other systemic anticancer therapy for the treatment of metastatic colorectal carcinoma including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) * Prior adjuvant chemotherapy (including oxaliplatin therapy) or other adjuvant systemic anticancer therapy including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) for the treatment of colorectal cancer ≤ 6 months prior to randomization with the following exceptions: Subjects may have received prior fluoropyrimidine therapy if administered solely for the purpose of radiosensitization for the adjuvant or neoadjuvant treatment of rectal cancer. * Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
AZ Sint Maarten Mechelen Antwerpen Recruiting
AZ Klina Brasschaat Antwerp Recruiting
University Hospital Antwerp Edegem Antwerp Recruiting
Sint-Augustinus (ZAS) Wilrijk Antwerp Recruiting
Grand Hopital de Charleroi Charleroi Henegouwen Recruiting
AZ Maria Middelares, Ghent Ghent Oost-Vlaanderen Recruiting
Vitaz Sint-Niklaas Oost-Vlaanderen Recruiting
AZ Sint Lucas, Brugge Bruges West-Vlaanderen Recruiting
AZ Groeninge, Kortrijk Kortrijk West-Vlaanderen Recruiting

More University Hospital, Antwerp trials in Belgium

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07558083 on ClinicalTrials.gov ↗ ← All trials in Belgium