{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2009"],"condition":["colorectal cancer"],"disease":["Colorectal Cancer"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2617787"],"location":["Japan"],"study_start_month":["7"],"repository":["ECRIN MDR"],"study_status":["Recruiting"],"additional_accession":[]},"is_claimable":false,"name":"Phase II study of combination chemotherapy with S-1 plus Avastin in unresectable or recurrent colorectal cancer after failure of prior chemotherapy, including irinotecan and oxaliplatin regimens.","description":"Interventions: A phase II study of third-line and subsequent treatment with S-1 alone performed in Korea in patients with unresectable, advanced or recurrent colorectal cancer reported a disease control rate of 42.9% (95% confidence interval, 23.3% to 62.4%). Because bevacizumab was combined with S-1 in the present study, a higher disease control rate is expected. The threshold rate was therefore set at 30% and the expected rate at 50%. Using Fleming’s single-stage procedure, we estimated that 35 patients would be required for the study to have a statistical power (1- ) of 0.80 or higher with a one-sided  value of 0.05. We assumed that more than 10% of enrolled patients would drop out of the study. The target number of enrolled patients was therefore set at 40.\nPrimary outcome(s): Disease control rate\nStudy Design: Single arm Non-randomized","dates":{"creation":"2009-07-15"},"accession":"2617787","cross_references":{"Japan Primary Registries Network":["JPRN-UMIN000002308"]}}