lead-in FOLICOLOR Trial: Following Therapy Response Through Liquid Biopsy in Metastatic Colorectal Cancer Patients
NCT ID: NCT04735900
Last Updated: 2021-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-09-14
2022-03-31
Brief Summary
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Detailed Description
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Inclusion is possible after histologically or cytologically proven colorectal adenocarcinoma with metastatic lesions according to RECIST 1.1 at the start of first-line treatment using FOLFOX/FOLFIRI and panitumumab. Patient must have a proven RAS and BRAF wild-type tumor.
Patients will be followed by study protocol up to and including the first CT scan following the last liquid biopsies taken, or when a follow-up period of 11 months is reached, until death, until metastasectomy, until lost to follow-up or until (consent) withdrawal.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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First-line FOLFOX/FOLFIRI and panitumumab.
Chemotherapeutic agents will be given as an intravenous infusion at a dose and interval consistent with standard institutional practice.
Liquid biopsy sampling
Biweekly liquid biopsy sampling to measure circulating tumor DNA (ctDNA) level up to and including 9 months after start first-line therapy.
Interventions
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Liquid biopsy sampling
Biweekly liquid biopsy sampling to measure circulating tumor DNA (ctDNA) level up to and including 9 months after start first-line therapy.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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 \[CTCAE version 5.0\])
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
University Hospital, Antwerp
OTHER
Responsible Party
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Principal Investigators
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Marc Peeters, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Antwerp University Hospital (UZA)
Locations
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AZ Klina
Brasschaat, , Belgium
Antwerp University Hospital (UZA)
Edegem, , Belgium
AZ Maria Middelares
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
AZ Nikolaas
Sint-Niklaas, , Belgium
GZA
Wilrijk, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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20/17/224
Identifier Type: -
Identifier Source: org_study_id
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