At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,254 enrolled
Drug / intervention
Cediranib +3 moredrug
Likely dose
XELOX (Capecitabine and Oxaliplatin) 130 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) When Added to 5 Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) With the Efficacy and Safety of Placebo When Added to FOLFOX or XELOX in Patients With Previously Untreated Metastatic Colorectal Cancer.
In Brief
A Phase 3 clinical trial evaluating Cediranib, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), and 2 other interventions for Metastatic Colorectal Cancer. Completed, enrolled 1,254 participants across 90 sites in 15 countries.
Detailed Summary
The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesArgentina, Australia, Brazil, Bulgaria, China, Czechia, Germany, Hungary, India, Philippines, Poland, South Korea, Switzerland, Taiwan, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2006
First PostedNov 2006
Primary CompletionMar 2010
Study CompletionAug 2016
TodayJul 2026
First PostedNov 14, 2006
Enrollment StartNov 1, 2006
Primary CompletionMar 1, 2010
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.6 years ago
Interventions
Cediranibdrug
oral tablet
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)drug
intravenous infusion
XELOX (Capecitabine and Oxaliplatin)drug
intravenous oxaliplatin 130 mg/ m\^2(day 1) followed by oral capecitabine 1,000 mg/ m\^2twice daily (day 1 to day 15)
Cediranib Placebodrug
oral tablet