Effects of mutations in KRAS and BRAF gene and histological parameters on the clinical course of disease in patients with metastatic colorectal cancer

The influence of mutation status in KRAS and BRAF gene according to the classical histological parameters of tumor as a predictive factor of the aggressive course of disease in metastatic colorectal cancer: a single centre, prospective, cohort trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10604174

Enrollment

400

Registered

2010-12-20

Start date

2010-11-29

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic colorectal cancer Cancer Malignant neoplasm of colon

Interventions

Patients with metastatic colorectal adenocarcinoma will be treated with combination chemotherapy and targeted drugs in accordance with the guidelines for the systemic treatment of metastatic colorecta

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. Histologically confirmed colorectal cancer 3. Diagnosis of metastatic disease 4. Age 18 to 75 years 5. Eastern Cooperative Oncology Group (ECOG) performance score 0 - 2 6. Life expectancy of at least 3 months 7. Primary tumor with described histological features 8. Histology available for further analysis and molecular diagnostics 9. Determination of BRAF mutations in KRAS gene before starting treatment 10. Adequate haematological function (ANC greater than or equal to 1.5 x 10/9L, platelets greater than or equal to 100 x 10/9/L, Hb greater than or equal to 90 g/L) 11. Adequate liver function (serum bilirubin less than or equal to 1.5 x ULN, AST/ALP less than or equal to 2.5 x ULN 12. In case of liver metastases less than 5 x ULN), adequate renal function (calculated creatinine clearance greater than or equal to 50 mL/min)

Exclusion criteria

Exclusion criteria: 1. ECOG performance score greater than 2 2. Participation in another clinical trial within 30 days prior to entering this study 3. Known hypersensitivity to any of the study drugs 4. Clinically significant cardiovascular disease (myocardial infarction less than or equal to 6 months before treatment start 5. Unstable angina 6. Uncontrolled hypertension 7. Arrhythmia requiring medication 8. Clinically significant renal disease (creatinine clearance less than 30 ml/min) 9. Liver cirrhosis Child B and C 10. Psychiatric disability to be clinically significant precluding informed consent 11. Evidence of any other disease 12. Metabolic dysfunction or laboratory findings, which give a suspicion of a disease or condition that contraindicates the use of any investigational drugs or means a higher risk for treatment-related complications

Design outcomes

Primary

Measure	Time frame
1. Progression-free survival (PFS) 2. Response rate (Response Evaluation Criteria in Solid Tumors [RECIST]) in correlation with histological parameters of tumor tissue, KRAS and BRAF status	—

Secondary

Measure	Time frame
Overall survival (OS)	—

Countries

Slovenia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026