NCT07558083 FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients
| NCT ID | NCT07558083 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Antwerp |
| Condition | Advanced Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-08-16 |
| Primary Completion | 2029-12 |
Trial Parameters
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Brief 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 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: Malignanc
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