Following therapy response with a blood test (liquid biopsy) in metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Timon Vandamme — University Hospital, Antwerp
• Study coordinator: Sanne Wouters
• Email: sanne.wouters@uza.be
• Phone: 003238212441

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.