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

NCT07558083 | Recruiting Phase 3 DMC

• 1 other identifier: 20/04/040
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 9

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.

Conditions

Advanced Colorectal Cancer

Keywords

NPY Methylation; Liquid Biopsy; advanced colorectal cancer patients

Outcome Measures

Primary Outcomes (1)

• Time to Deterioration (TTD) in Quality of Life (QoL)

  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.

  18 months

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  18 months

• 3 year overall survival

  3 year

• Earlier detection of progressive disease with liquid biospies

  18 months

Study Arms (2)

CT arm

NO INTERVENTION

Treatment decision guided by radiographic evaluation following the standard of care of the treating hospital. (Control arm)

Liquid Biopsy arm

EXPERIMENTAL

Treatment decision guided by liquid biopsies. (intervention arm)

Other: Evaluation therapy through Liquid Biopsy

Interventions

Evaluation therapy through Liquid Biopsy OTHER

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

Liquid Biopsy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Kom Op Tegen Kanker: collaborator
• University Hospital, Antwerp: lead

Study Sites (9)

AZ Sint Maarten

Mechelen, Antwerpen, 2800, Belgium

RECRUITING

AZ Klina

Brasschaat, Antwerp, 2930, Belgium

RECRUITING

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

Sint-Augustinus (ZAS)

Wilrijk, Antwerp, 2610, Belgium

RECRUITING

Grand Hopital de Charleroi

Charleroi, Henegouwen, 6020, Belgium

RECRUITING

AZ Maria Middelares, Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Vitaz

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

RECRUITING

AZ Sint Lucas, Brugge

Bruges, West-Vlaanderen, 8000, Belgium

RECRUITING

AZ Groeninge, Kortrijk

Kortrijk, West-Vlaanderen, 8500, Belgium

RECRUITING

Study Officials

• Timon Vandamme

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanne Wouters

CONTACT

003238212441; sanne.wouters@uza.be

Ayla Wyninckx

CONTACT

003232759745; ayla.wyninckx@uza.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: * CT-arm: Liquid Biopsies results are blinded for care provider (oncologist en study coordinator), except the screening LB result for checking eligibility. * LB arm: Liquid Biopsies are unblinded every 2 months, on an evaluation timepoint. All other LB are blinded (except for exceptions, described in protocol)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * ARM 1 (control arm or CT arm): Treatment decision guided by radiographic evaluation. * ARM 2 (intervention arm or LB arm): Treatment decision guided by liquid biopsies.

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: April 30, 2026
• Study Start: August 16, 2021
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): August 1, 2031
• Last Updated: April 30, 2026

Record last verified: 2026-03

Locations

BE (9)