Randomized Phase II study of Bevacizumab with SOX versus Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: SOX+Bevacizumab Bevacizumab 7.5mg/kg/triweekly L‐OHP 130 mg/m2/triweekly TS‐1 80,100,120 mg/twice/day 1‐14, following one week off XELOX+Bevacizumab Bevacizumab 7.5mg/kg/triweekly L‐OHP 130 mg/m2/triweekly Capecitabine 2400‐4200 mg/twice/day 1‐14, following one week off CONDITION: Metastatic colorectal cancer PRIMARY OUTCOME: Progression‐free survival (PFS) SECONDARY OUTCOME: Response rate (RR); Time to treatment failure (TTF); Overall Survival (OS); Safety profile INCLUSION CRITERIA: (1) Patients with histologically proven colorectal cancer (2) Metastatic colorectal cancer (3) Age over 20 (4) ECOG Performance Status (PS) 0‐1 (5) A measurable or evaluable lesion is confirmed with objective documents such as CT, MRI and the X‐ray check within 30th before registration (a measurable lesions in RECIST criteria is unnecessary) (6) Metastatic colorectal cancer which has prior therapy of S‐1 and CPT‐11 (7) Ability of oral intake (8) Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function as evidenced by the following data within two weeks before registration (9) Life expectancy of more than 3 months (10) Written informed consent
Epistemonikos ID: 867e54e95b94972149cec58965c6902c1826f013
First added on: Aug 22, 2024