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

Not Applicable

Completed

• Conditions: Metastatic colorectal cancer; Cancer; Malignant neoplasm of colon

• Registration Number: ISRCTN10604174
• Lead Sponsor: Institute of Oncology Ljubljana (Slovenia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-20
• Study Completion: 2013-12-31
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)