{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2023"],"data_sharing_plan":["IPD Sharing (as of October 2023): No"],"condition":["Adenocarcinoma","Colorectal Adenocarcinoma","Neoplasm, Colorectal","Colorectal Cancer","Colorectal Neoplasms","Colorectal Cancer Metastatic","Neoplasms","Adenocarcinoma metastásico de colon o recto recidivante, irresecable, confirmado histológica o citológicamente con enfermedad radiológicamente medible.","Relapsed, unresectable, histologically or cytologically confirmed metastatic adenocarcinoma of colon or rectum with radiologically measurable disease."],"disease":["Adenocarcinoma","Colorectal Adenocarcinoma","Neoplasm, Colorectal","Colorectal Cancer","Colorectal Neoplasms","Colorectal Cancer Metastatic","Relapsed, Unresectable, Histologically Or Cytologically Confirmed Metastatic Adenocarcinoma Of Colon Or Rectum With Radiologically Measurable Disease.","Adenocarcinoma Metastásico De Colon O Recto Recidivante, Irresecable, Confirmado Histológica O Citológicamente Con Enfermedad Radiológicamente Medible.","Neoplasms"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/4510"],"location":["United States","Italy","United Kingdom","France","Germany","Spain"],"study_start_month":["4"],"keyword":["Metastatic cancer","Locally advanced cancer","Levoleucovorin","Leucovorin","Antineoplastic agents","NUC-3373 for infusion","Bevacizumab","Neoplasm","Second-line chemotherapy","Irinotecan","Chemotherapy","Relapsed metastatic adenocarcinoma of colon/rectum","NUC-3373","Fosifloxuridine nafalbenamide","5-FU","Fluorouracil"],"repository":["ECRIN MDR"],"study_status":["Recruiting"],"additional_accession":[]},"is_claimable":false,"name":"A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer","description":"This is a randomized, open-label, dose/schedule optimization study comparing NUC-3373/leucovorin (LV)/irinotecan plus bevacizumab (NUFIRI-bev) to 5-FU/LV/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with unresectable metastatic colorectal cancer.\nA total of 171 patients will be randomized 1:1:1 to either NUFIRI-bev on a weekly NUC-3373 schedule, NUFIRI-bev based on an alternate weekly NUC-3373 schedule, or FOLFIRI bev on an alternate weekly schedule. The main objectives are to assess and compare the efficacy and safety of the 3 regimens. Pharmacokinetics will be assessed on the 2 NUFIRI arms.","dates":{"creation":"2023-04-15"},"accession":"4510","cross_references":{"ClinicalTrials___gov":["NCT05678257"],"EU Clinical Trials Register":["2022-001459-17"]}}