Effect of Silymarin in Metastatic Colorectal Cancer Patients
Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: - Patients with histologically and/or radiologically confirmed diagnosis of metastatic colorectal carcinoma. Patients who received FOLFOX or XELOX as first line chemotherapy Both genders. Age ≥18 years old. Performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG). Patients with adequate hematologic parameters (white blood cell count ≥3000/mm3, granulocytes ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥ 8 gm/l). Patients with adequate renal functions (serum creatinine ≤1.5 mg/dL). Patients with adequate hepatic functions (bilirubin ≤1.5 mg/dL or albumin ≥3 g/dL). Exclusion Criteria: - Patients with active liver diseases (chronic viral hepatitis, autoimmune hepatitis, alcoholic hepatitis, Wilson's disease, hemochromatosis, or cirrhosis). Patients with a history of other malignancy. Patients with brain metastasis. Patients with active infection. Patients with RAS wild type cancer. Patients on chronic use of corticosteroids.
Sites / Locations
- faculty of Pharmacy , Tanta University
Arms of the Study
Arm 1
Arm 2
No Intervention
Active Comparator
Control group
Silymarin group
Group I (Control group ; n=32) which will receive FOLFIRI regimen (5-flourouracil, leucovorin, irinotecan) or XELIRI (Capecitabine and irinotecan) with or without target therapy (Bevacizumab).
Group II: (Silymarin group ; n=32) which will receive FOLFIRI regimen (5-flourouracil, leucovorin, irinotecan) or XELIRI (Capecitabine and irinotecan) with or without target therapy (Bevacizumab). plus silymarin 140 mg once daily.