Other Oncogene Mutations for Anti-EGFR Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer

Korábbi kezelés

• Previous systemic therapy for metastatic disease.
• Complicated primary tumor, requiring urgent surgical intervention. After it is eliminated, the patient can participate in the study.

Más betegség

• The presence of any other malignant tumor, with the exception of radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years before inclusion in the study. Pregnant and lactating women, as well as planning pregnancy during the period of therapy in a clinical trial and 6 months after the end of therapy.
• HIV infection, active hepatitis B, active hepatitis C.
• The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the study.

Egyéb

• Presence of KRAS/NRAS/V600E mutations (except for unknown BRAF status).
• Uncertain KRAS/NRAS status
• Impossibility of organizing central venous access.

• Informed consent signed before commencing any procedures related to the clinical trial.
• Age ≥18 years.
• ECOG status 0-2.
• Life expectancy greater than 12 weeks as assessed by the investigator.
• Verified diagnosis of colorectal adenocarcinoma (C18.5, C19, C20).
• Metastatic unresectable form of the disease that has not previously received any systemic therapy for the metastatic process (previous neo-/adjuvant therapy completed at least 6 months before the detection of metastases is allowed).
• Left-sided localization of the primary tumor (from the splenic flexure of the colon inclusive).
• Verified wild type KRAS, NRAS determined from tumor tissue.
• Satisfactory function of hematopoiesis and internal organs:
  • absolute number of neutrophils ≥ 1.5×10 9 /l;
  • platelets ≥ 100×10 9 /l;
  • hemoglobin ≥ 90 g/l.
  • creatinine clearance above 50 ml/min;
  • total bilirubin <1.5 X the upper limit of normal;
  • ALT or AST >5 X the upper limit of normal in the presence of liver metastases or >2.5 X the upper limit of normal in the absence of liver metastases.
• Availability of a sufficient amount of tumor material for molecular genetic research. Tumor material must be collected no more than 24 months before inclusion in the study.