{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2018"],"data_sharing_plan":["IPD Sharing (as of April 2023): Undecided"],"condition":["Malignant neoplasm of colon, Malignant neoplasm of rectum","Metastatic Colorectal Cancer","Colorectal Neoplasms","C18.9, C20","RAS wild-type Metastatic Colorectal Cancer"],"disease":["Metastatic Colorectal Cancer","Malignant Neoplasm Of Colon, Malignant Neoplasm Of Rectum","Colorectal Neoplasms","C18.9, C20","Ras Wild-type Metastatic Colorectal Cancer"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2262710"],"location":["Iran"],"study_start_month":["1"],"keyword":["Irinotecan","Leucovorin","RAS Wild-type","Cetuximab","Fluorouracil"],"repository":["ECRIN MDR"],"study_status":["Recruiting"],"additional_accession":[]},"is_claimable":false,"name":"Comparing Efficacy and Safety of Cetuximab (CinnaGen) Versus Erbitux (Merck) in Metastatic Colorectal Cancer","description":"The study is designed as phase III, randomized, two armed, parallel, double blind (patient and assessor blinded), active controlled, and equivalency clinical trial with primary endpoint of Progression-Free Survival of Cetuximab (produced by CinnaGen) compared with Erbitux (Cetuximab, the reference drug) in patients with RAS wild-type Metastatic Colorectal Cancer with the allocation ratio of 2:1.Patients who met the following criteria could be recruited to receive the mentioned intervention randomly. Inclusion criteria: Male or female older than 18 years old, histologically confirmed adenocarcinoma of the colon or rectum which is metastatic, having one or more bi-dimensionally measurable lesions as defined by RECIST criteria, tumor that could not be resected for curative purposes,ECOG performance status score of 2 or less,life expectancy of longer than 3 months (clinical assessment),evidence of tumor EGFR expression (expanded wild-type RAS),adequate organ and marrow function as defined:\nANC ≥ 1,500/mm3 Plt ≥ 100,000/mm3 Hb ≥ 9 g/dL (may have had blood transfusions) AST/ALT ≤ 2.5 IULN or ≤ 5 IULN with known liver metastases Total bilirubin ≤ 1.5 IULN Serum Creatinine ≤ 1.5 IULN INR ≤ 1.5 and PTT ≤ 1.5 IULN","dates":{"creation":"2018-01-15"},"accession":"2262710","cross_references":{"ClinicalTrials___gov":["NCT03391934"],"Iranian Registry of Clinical Trials":["IRCT2017110821315N10"]}}