ecrin-mdr-crcClinical2023IPD Sharing (as of October 2023): NoAdenocarcinomaColorectal AdenocarcinomaNeoplasm, ColorectalColorectal CancerColorectal NeoplasmsColorectal Cancer MetastaticNeoplasmsAdenocarcinoma 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.AdenocarcinomaColorectal AdenocarcinomaNeoplasm, ColorectalColorectal CancerColorectal NeoplasmsColorectal Cancer MetastaticRelapsed, 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.NeoplasmsInterventionalhttps://newmdr.ecrin.org/Study/4510United StatesItalyUnited KingdomFranceGermanySpain4Metastatic cancerLocally advanced cancerLevoleucovorinLeucovorinAntineoplastic agentsNUC-3373 for infusionBevacizumabNeoplasmSecond-line chemotherapyIrinotecanChemotherapyRelapsed metastatic adenocarcinoma of colon/rectumNUC-3373Fosifloxuridine nafalbenamide5-FUFluorouracilECRIN MDRRecruitingfalseA Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal CancerThis 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. A 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.2023-04-154510NCT056782572022-001459-17