{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2014"],"condition":["Colorectal cancer metastatic","The present proposal is aimed to evaluate the efficacy and safety of regorafenib as maintenance therapy in increasing the efficacy of the best available therapy for first line treatment fluoropirimidine based chemotherapy , any variant, in combination with either cetuximab or panitumumab) of RAS wild type metastatic colorectal cancer patients.","Ziel der vorliegenden Studie ist die Evaluierung der Wirksamkeit und Sicherheit von Regorafenib als Erhaltungstherapie zur Erhöhung der Wirksamkeit der besten verfügbaren Therapie zur Erstbehandlung (Fluoropirimidine basierte Chemotherapie in jeder Variante, in Kombination mit entweder Cetuximab oder Panitumumab) für Patienten mit metastasiertem Kolorektalkarzinom des Typs RASwild.","Metastatic colorectal cancer"],"disease":["Metastatic Colorectal Cancer","The Present Proposal Is Aimed To Evaluate The Efficacy And Safety Of Regorafenib As Maintenance Therapy In Increasing The Efficacy Of The Best Available Therapy For First Line Treatment Fluoropirimidine Based Chemotherapy , Any Variant, In Combination With Either Cetuximab Or Panitumumab) Of Ras Wild Type Metastatic Colorectal Cancer Patients.","Colorectal Cancer Metastatic","Ziel Der Vorliegenden Studie Ist Die Evaluierung Der Wirksamkeit Und Sicherheit Von Regorafenib Als Erhaltungstherapie Zur Erhöhung Der Wirksamkeit Der Besten Verfügbaren Therapie Zur Erstbehandlung (fluoropirimidine Basierte Chemotherapie In Jeder Variante, In Kombination Mit Entweder Cetuximab Oder Panitumumab) Für Patienten Mit Metastasiertem Kolorektalkarzinom Des Typs Raswild."],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2532813"],"location":["Germany","Spain"],"study_start_month":["12"],"keyword":["Stivarga"],"repository":["ECRIN MDR"],"study_status":["Ongoing"],"additional_accession":[]},"is_claimable":false,"name":"maintenance therapy with regorafenib","description":"Primary objectives: The objective of this study is to evaluate efficacy and safety of regorafenib in the maintenance of the response in patients with metastatic colorectal (CRC) RAS wild type after first line therapy\n(fluoropirimidine-based plus anti-EGFR Abs). The primary efficacy endpoint of this study is Progression Free Survival (PFS) defined as the time(days) from randomization for maintenance therapy with study drug to PD or death whichever comes first.\nPrimary endpoints: Progression-free Survival (PFS)","dates":{"creation":"2014-12-15"},"accession":"2532813","cross_references":{"EU Clinical Trials Register":["2013-005428-41"]}}