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)
Time to Deterioration (TTD) in Quality of Life (QoL) — 18 months The primary objective of this study is to determine whether the technique of monitoring patients with liquid biopsies can ensure that patients experience a slower decline in their quality of life (and can therefore maintain a good quality of life for longer).
This will be evaluated through the difference in time to deterioration (TTD) in Quality of Life (QoL) between patients in which follow-up is done based on the results of LBs (LB-arm) in comparison to the patients in which follow-up is done based on the conventional follow-up techniques (CT-arm). TTD is defined as time from randomization to the first decrease from baseline on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ-CR29) summary score by at least 10 percent.
Trial sites (9)
Facility
City
Region
Status
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
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.
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