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Compares treatment options for Colorectal Cancer
Official title Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB
ClinicalTrials.gov ID: NCT04776655
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, being studied as a potential treatment for colorectal cancer.
Also referred to as Avastin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, randomized phase III, to evaluate if in patients with mCRC RAS/BRAF wild type on tumor tissue and RAS mutations on liquid biopsy, treating in first line with antibody anti-VEGF (bevacizumab) plus chemotherapy (FOLFIRI) is superior in terms of PFS compared to standard treatment with antibody anti-EGFR (cetuximab) plus FOLFIRI, and then in patients RAS/BRAF wild type on tumor tissue who develop RAS mutations on liquid biopsy after the beginning of the first line treatment with cetuximab plus FOLFIRI, in the absence of a clinical or radiological progression disease, to anticipate a change of treatment with bevacizumab plus FOLFIRI further impacts on the PFS.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of written informed consent;
- Male or female \> 18 years of age;
- Histologically confirmed diagnosis of colorectal adenocarcinoma RAS/BRAF wild type (analysed either on primary and/or related metastasis);
- Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease;
- Patient with left colorectal cancer;
You likely can't join if
- Previous chemotherapy treatment, with the exception of patient treated in adjuvant setting completed at least 6 months before the randomization;
- Any contraindication to the use of Cetuximab, Bevacizumab, Irinotecan, 5FU or folinic acid;
- Radiotherapy to any site within 4 weeks before the randomization;
- Serious, non-healing wound, ulcer, or bone fracture;
- Evidence of bleeding diathesis or coagulopathy;
- Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy;
See the full eligibility criteria
- Provision of written informed consent;
- Male or female \> 18 years of age;
- Histologically confirmed diagnosis of colorectal adenocarcinoma RAS/BRAF wild type (analysed either on primary and/or related metastasis);
- Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease;
- Patient with left colorectal cancer;
- Patients suitable for first line chemotherapy;
- Life expectancy \> 3 months;
- At least one site of measurable disease per RECIST criteria ver. 1.1;
- ECOG Performance status = 2;
- Adequate bone marrow, liver and renal function assessed before starting study treatment;
- If DPD status is known it must be wild type. No restrictions are applied if DPD status in unknown;
- Women of childbearing potential must have a negative blood pregnancy test within 24 hr prior to the start of study treatment. For this trial, women of childbearing potential are defined as all women after puberty...
- people and their partners must be willing to avoid pregnancy during the trial and until 5 months for WOCBP (Women of Childbearing Potential) and 7 months for male people with female partners of WOCBP after the last...
- Previous chemotherapy treatment, with the exception of patient treated in adjuvant setting completed at least 6 months before the randomization;
- Any contraindication to the use of Cetuximab, Bevacizumab, Irinotecan, 5FU or folinic acid;
- Radiotherapy to any site within 4 weeks before the randomization;
- Serious, non-healing wound, ulcer, or bone fracture;
- Evidence of bleeding diathesis or coagulopathy;
- Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy;
- Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy;
- Active and untreated brain (CNS) metastases and/or carcinomatous meningitis;
- Active infection requiring systemic therapy or active disseminated intravascular coagulation;
- History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antobodies);
- Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection;
- Chronic, daily treatment with high-dose aspirin (\>325 mg/day);
- Any previous venous thromboembolism \> NCI CTCAE Grade 3;
- History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment. History of acute or subacute intestinal occlusion or chronic inflammatory...
- Current, recent (within 10 days prior to study treatment start) or ongoing treatment with anticoagulants for therapeutic purposes;
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study;
- History of any severe hypersensitivity reactions to any monoclonal antibody;
- A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
The study team makes the final eligibility decision.
Where it's taking place
- Coppito, L'Aquila, Italy
- Guastalla, Reggio Emilia, Italy
- Reggio Emilia, Reggio Emilia, Italy
- Mirano, VE, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Coppito, L'Aquila, Italy; Guastalla, Reggio Emilia, Italy; Reggio Emilia, Reggio Emilia, Italy; Mirano, VE, Italy. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.