Status:
UNKNOWN
lead-in FOLICOLOR Trial: Following Therapy Response Through Liquid Biopsy in Metastatic Colorectal Cancer Patients
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Amgen
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Detection of progressive disease by neuropeptide Y (NPY) methylation in liquid biopsies in patients with RAS and BRAF wild-type, unresectable, metastatic colorectal cancer receiving first-line treatme...
Detailed Description
Prospective, multicentric interventional study to optimize the cutoff value of NPY methylation in liquid biopsies in metastatic colorectal cancer patients treated with first-line FOLFOX/FOLFIRI and pa...
Eligibility Criteria
Inclusion
- Man or woman ≥ 18 years of age at the time the informed consent is obtained
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic (M1) disease
- At least 1 uni-dimensionally measurable lesion of at least 10 mm per RECIST 1.1 guidelines using conventional techniques (CT scan). Lesion must not be chosen from a previously irradiated field, unless there has been documented disease progression in that field after irradiation and prior to inclusion. All sites of disease must be evaluated \<28 days prior to the start of first-line therapy
- Wild-type RAS tumor status (of tumor tissue)
- Wild-type BRAF tumor status (of tumor tissue)
- Adequate hematologic, renal, hepatic and coagulation function
- Starting a first-line treatment with a combination of FOLFOX/FOLFIRI and panitumumab
Exclusion
- 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 start therapy 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-Epidermal Growth Factor Receptor (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 start therapy 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 start therapy. Subjects must have recovered from all radiotherapy-related toxicities.
- Significant cardiovascular risk
- History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on diagnostic CT scan
- Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as ≥ Common Terminology Criteria (CTC) grade 2, \[Common Terminology Criteria for Adverse Events (CTCAE) version 5.0\])
- Peripheral sensory neuropathy (≥ CTC grade 2 \[CTCAE version 5.0\])
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04735900
Start Date
September 14 2020
End Date
March 1 2022
Last Update
February 3 2021
Active Locations (6)
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1
AZ Klina
Brasschaat, Belgium, 2930
2
Antwerp University Hospital (UZA)
Edegem, Belgium, 2650
3
AZ Maria Middelares
Ghent, Belgium, 9000
4
AZ Groeninge
Kortrijk, Belgium, 8500