<HashMap><database>ecrin-mdr-crc</database><scores/><additional><omics_type>Clinical</omics_type><study_start_year>2014</study_start_year><condition>Carcinoma colorettale metastatico (mCRC)</condition><condition>METASTATIC COLORECTAL CANCER</condition><disease>Metastatic Colorectal Cancer</disease><disease>Carcinoma Colorettale Metastatico (mcrc)</disease><study_type>Interventional</study_type><full_dataset_link>https://newmdr.ecrin.org/Study/2533812</full_dataset_link><location>Italy</location><study_start_month>12</study_start_month><keyword>Oxaliplatino</keyword><keyword>Irinotecan</keyword><keyword>5 Fluorouracile</keyword><keyword>acido levo-folinico (L-Leucovorin)</keyword><keyword>Bevacizumab</keyword><repository>ECRIN MDR</repository><study_status>Ongoing</study_status></additional><is_claimable>false</is_claimable><name>Phase III study to compare two different chemotherapy treatments to determine whether the first line with the three drugs + bevacizumab followed by a second line with the same regimen may provide better results than treatment with two drugs + bevacizumab is the first and the second treatment line</name><description>Primary objectives: The main objective of this trial is to compare the efficacy of the two proposed treatment strategies in terms of duration of Progression Free Survival 2 (PFS2).
Primary endpoints: The primary endpoint is Progression Free Survival 2 (PFS2).PFS2 will be defined as beginning with randomization and ending with the first of the following events: a) death; b) disease progression on any treatment given after 1st progression. For patients that will not receive any treatment within 3 months after 1st progression, PFS2 will be equal to PFS. The determination of disease progression will be based on investigator-reported measurements. Disease status will be evaluated according to RECIST 1.1 criteria.Censoring rules for PFS2 will be: end of study without PD, loss at follow-up. Curative surgery for metastasis will not result in censoring for PFS2.PFS2 will be analyzed both in the intention-to-treat population (primary analysis) and in the per-protocol population.</description><dates><creation>2014-12-15</creation></dates><accession>2533812</accession><cross_references><EU Clinical Trials Register>2014-004436-19</EU Clinical Trials Register></cross_references></HashMap>