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Phase 3 Study of Anti-EGFR Antibodies with FOLFOX Chemotherapy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer Evaluating the Impact of Other Oncogene Mutations on Treatment Effectiveness
Led by City Clinical Oncology Hospital No 1 · Updated on 2024-01-29
355
Participants Needed
3
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying patients with unresectable metastatic colorectal cancer located on the left side of the colon, who have not received prior systemic therapy for metastatic disease and have specific genetic profiles related to KRAS, NRAS, and BRAF genes. The study aims to evaluate how other oncogene mutations affect the effectiveness of anti-EGFR monoclonal antibody therapies in these patients. This is a phase III randomized trial designed to compare treatment outcomes based on genetic profiles. Participants will be randomly assigned to one of two groups Cohort A, which receives combination chemotherapy called FOLFOX along with anti-EGFR therapy panitumumab or cetuximab according to clinical guidelines or Cohort BC, which starts FOLFOX chemotherapy and undergoes detailed genetic profiling. Based on this profiling, Cohort BC splits into Cohort B patients without alternative oncogene changes who receive anti-EGFR therapy plus chemotherapy, and Cohort C patients with alternative oncogene changes who continue chemotherapy alone or receive bevacizumab if suitable. Treatment continues until disease progression or unacceptable side effects. During the study, patients will have ongoing assessments including genetic testing, treatment monitoring, and evaluation of disease progression. The main outcome measured is progression-free survival over an average of three years. Researchers will also track adverse events and overall survival. The study includes detailed monitoring of blood counts and organ function, with treatment adjustments allowed if needed. Participants remain under close observation throughout the trial period, which extends until the studys completion around late 2027.
CONDITIONS
Brief Title
Other Oncogene Mutations for Anti-EGFR Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer
Research Team
I
Ilya Pokataev, phD
M
Maria Byakhova, phD
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