About this trial
The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.
Eligibility criteria
Qualifiers
Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.
Age ≥18 years at the time of informed consent
ECOG performance status (PS) of 0-2
Written informed consent prior to study-specific screening procedures
Disqualifiers
History of other malignancy with a disease-free interval <5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)
With massive pleural effusion or ascites requiring intervention
Radiological evidence of brain tumor or brain metastases
Active infection including hepatitis
Trial design
Treatments tested in this trial
- Bevacizumab
- CPT-11
- 5-FU Bolus
- 5-FU Infusion
- l-LV (dl-LV)