Spots Global Cancer Trial Database for Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Official Title: Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Study ID: NCT00851084
Study Description
Brief Summary: The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study. Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept. This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints. Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sanofi-Aventis Investigational Site Number 036004, Douglas, , Australia
Sanofi-Aventis Investigational Site Number 036001, Hunter Region Mail Centre, , Australia
Sanofi-Aventis Investigational Site Number 036003, Hunter Region Mail Centre, , Australia
Sanofi-Aventis Investigational Site Number 276003, Berlin, , Germany
Sanofi-Aventis Investigational Site Number 276007, Dresden, , Germany
Sanofi-Aventis Investigational Site Number 276001, Hannover, , Germany
Sanofi-Aventis Investigational Site Number 276006, Homberg, , Germany
Sanofi-Aventis Investigational Site Number 276004, Mannheim, , Germany
Sanofi-Aventis Investigational Site Number 276002, Münster, , Germany
Sanofi-Aventis Investigational Site Number 276005, Recklinghausen, , Germany
Sanofi-Aventis Investigational Site Number 380005, Bari, , Italy
Sanofi-Aventis Investigational Site Number 380001, Firenze, , Italy
Sanofi-Aventis Investigational Site Number 380002, Milano, , Italy
Sanofi-Aventis Investigational Site Number 380003, Taormina, , Italy
Sanofi-Aventis Investigational Site Number 380004, Torino, , Italy
Sanofi-Aventis Investigational Site Number 410003, Busan, , Korea, Republic of
Sanofi-Aventis Investigational Site Number 410004, Cheongju, , Korea, Republic of
Sanofi-Aventis Investigational Site Number 410005, Daegu, , Korea, Republic of
Sanofi-Aventis Investigational Site Number 410002, Daejeon, , Korea, Republic of
Sanofi-Aventis Investigational Site Number 410007, Goyang-Si, Gyeonggi-Do, , Korea, Republic of
Sanofi-Aventis Investigational Site Number 410006, Seoul, , Korea, Republic of
Sanofi-Aventis Investigational Site Number 410001, Seoul, , Korea, Republic of
Sanofi-Aventis Investigational Site Number 410008, Ulsan, , Korea, Republic of
Sanofi-Aventis Investigational Site Number 643002, Pyatigorsk, , Russian Federation
Sanofi-Aventis Investigational Site Number 643005, Saint-Petersburg, , Russian Federation
Sanofi-Aventis Investigational Site Number 643001, Sochi, , Russian Federation
Sanofi-Aventis Investigational Site Number 724005, Barcelona, , Spain
Sanofi-Aventis Investigational Site Number 724004, Madrid, , Spain
Sanofi-Aventis Investigational Site Number 724001, Madrid, , Spain
Sanofi-Aventis Investigational Site Number 724002, Sabadell, , Spain
Sanofi-Aventis Investigational Site Number 724007, Santiago De Compostela, , Spain
Sanofi-Aventis Investigational Site Number 724003, Valencia, , Spain
Sanofi-Aventis Investigational Site Number 826004, Leeds, , United Kingdom
Sanofi-Aventis Investigational Site Number 826001, Leicester, , United Kingdom
Sanofi-Aventis Investigational Site Number 826002, Manchester, , United Kingdom
Sanofi-Aventis Investigational Site Number 826003, Slough, , United Kingdom
Sanofi-Aventis Investigational Site Number 826005, Southampton, , United Kingdom
Contact Details
Name: John Zalcberg, MD
Affiliation: Peter Mc Callum Cancer Centre, Melbourne, Australia
Role: PRINCIPAL_INVESTIGATOR
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