Following therapy response with a blood test (liquid biopsy) in metastatic colorectal cancer
FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients
This trial tests whether using a blood test that measures NPY-methylation ctDNA to guide treatment decisions helps people with unresectable metastatic colorectal cancer who are starting first-line therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Drugs / interventions | bevacizumab, cetuximab, panitumumab, erlotinib, gefitinib, lapatinib, chemotherapy |
| Locations | 9 sites (Mechelen, Antwerpen and 8 other locations) |
| Trial ID | NCT07558083 on ClinicalTrials.gov |
What this trial studies
FOLICOLOR is a prospective, randomized, open-label, multicenter phase 3 trial comparing standard CT-scan–guided follow-up to a liquid biopsy–guided follow-up using serial NPY-methylation ctDNA measurements. Eligible patients with detectable NPY-methylation ctDNA at baseline are randomized to either CT imaging–guided decisions or ctDNA-guided decisions during first-line systemic therapy. Patients are followed for 18 months with predefined schedules for blood sampling, imaging, and clinical visits. The primary aim is to preserve quality of life and reduce exposure to ineffective or toxic treatment, with secondary endpoints including earlier detection of progression, progression-free survival, and overall survival.
Who should consider this trial
Good fit: Adults (≥18) with unresectable metastatic colorectal adenocarcinoma starting first-line systemic therapy, ECOG 0–2, at least one measurable lesion, and detectable NPY-methylation ctDNA at baseline are ideal candidates.
Not a fit: Patients without detectable NPY-methylation ctDNA at baseline, those with prior CNS metastases, resectable disease, or not starting first-line therapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could help patients maintain quality of life longer and reduce exposure to ineffective or toxic therapies by enabling earlier, personalized treatment changes based on blood results.
How similar studies have performed: Smaller observational and early-phase studies have shown ctDNA can detect progression earlier than imaging, but randomized phase 3 evidence for ctDNA-guided follow-up is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Mechelen, Antwerpen and 8 other locations
- AZ Sint Maarten — Mechelen, Antwerpen, Belgium (Recruiting)
- AZ Klina — Brasschaat, Antwerp, Belgium (Recruiting)
- University Hospital Antwerp — Edegem, Antwerp, Belgium (Recruiting)
- Sint-Augustinus (ZAS) — Wilrijk, Antwerp, Belgium (Recruiting)
- Grand Hopital de Charleroi — Charleroi, Henegouwen, Belgium (Recruiting)
- AZ Maria Middelares, Ghent — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
- Vitaz — Sint-Niklaas, Oost-Vlaanderen, Belgium (Recruiting)
- AZ Sint Lucas, Brugge — Bruges, West-Vlaanderen, Belgium (Recruiting)
- AZ Groeninge, Kortrijk — Kortrijk, West-Vlaanderen, Belgium (Recruiting)
Study contacts
- Principal investigator: Timon Vandamme — University Hospital, Antwerp
- Study coordinator: Sanne Wouters
- Email: sanne.wouters@uza.be
- Phone: 003238212441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.