{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2016"],"data_sharing_plan":["IPD Sharing (as of September 2020): No"],"condition":["C18-9","Metastatic Colorectal Cancer","Colorectal Neoplasms","Malignant neoplasm of colon"],"disease":["C18-9","Metastatic Colorectal Cancer","Colorectal Neoplasms","Malignant Neoplasm Of Colon"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2254808"],"location":["Iran","Aland Islands"],"study_start_month":["10"],"keyword":["Irinotecan","Leucovorin","Fluorouracil","Bevacizumab"],"repository":["ECRIN MDR"],"study_status":["Completed"],"additional_accession":[]},"is_claimable":false,"name":"Comparing Efficacy and Safety of Stivant (AryoGen Bevacizumab) Versus Avastin in Metastatic Colorectal Cancer","description":"This is a Phase III, randomized, two arms, double-blind (patient and assessor blinded), parallel active non inferiority controlled clinical trial with a 2:1 allocation. This trial was conducted to evaluate the efficacy and safety of bevacizumab (produced by AryoGen Pharmed) plus FOLFIRI-3 compared with bevacizumab (Avastin) plus FOLFIRI-3 in patients with metastatic colorectal cancer (mCRC). Patients who met the following criteria could be recruited to receive the mentioned intervention randomly. Inclusion criteria: male or female aged 18-75 years, mCRC verified histologically, Having one or more bi-dimensionally measurable lesions as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, Was not felt to be amenable to curative resection, With an (ECOG) performance status of ≤ 1, Life expectancy of longer than 3 months, Adequate organ and marrow function, May have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent disease was documented, Patients with history of hypertension must be well-controlled (blood pressure less than/equal to 150/100), on a stable regimen of anti-hypertensive therapy.","dates":{"creation":"2016-10-15"},"accession":"2254808","cross_references":{"ClinicalTrials___gov":["NCT03288987"],"Iranian Registry of Clinical Trials":["IRCT2015072517994N2"]}}