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

Recruiting now · Phase 3

Conditions studied: Advanced Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT07558083

Run by

University Hospital, Antwerp

People needed

150

Starts

2021-08-16

Expected to finish

2031-08-01

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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