Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus C… (NCT04776655) | Clinical Trial Compass
RecruitingPhase 3
Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB
Italy280 participantsStarted 2021-04-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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;
Exclusion criteria
✕. 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;
What they're measuring
1
Progression free survival (PFS) in patients with RASmut at liquid biopsy and RASwt on tissue.
Timeframe: From the date of randomization to the date of first progression or death for any cause, whichever occurs first, assessed up to 36 months
✕. 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;