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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.

First Line Metastatic Colorectal Cancer Therapy in Combination with FOLFOX

Research Site

A Randomised, Double-blind, Multicentre Phase II/III Study to Compare the Efficacy of Cediranib (RECENTIN™, AZD2171) in Combination with 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination with FOLFOX in Patients with Previously Untreated Metastatic Colorectal Cancer

Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.

Number of months from randomisation to the date of death from any cause

Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below:
CR = Disappearance of all target lesions.
PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.

Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication.  Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009.

Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100

Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded.

Arms	Assigned Interventions
Active Comparator: 1 Bevacizumab + FOLFOX	Drug: Bevacizumab intravenous infusion Other Name: Avastin® Drug: 5-fluorouracil ( in FOLFOX) intravenous infusion Other Name: 5-FU Drug: Leucovorin (in FOLFOX) intravenous infusion Drug: Oxaliplatin (in FOLFOX) intravenous infusion Other Name: Eloxatin®
Experimental: 2 Cediranib + FOLFOX	Drug: Cediranib oral tablet once daily Other Name: RECENTIN™ Other Name: AZD2171 Drug: 5-fluorouracil ( in FOLFOX) intravenous infusion Other Name: 5-FU Drug: Leucovorin (in FOLFOX) intravenous infusion Drug: Oxaliplatin (in FOLFOX) intravenous infusion Other Name: Eloxatin®

First Line Metastatic Colorectal Cancer Therapy in Combination with FOLFOX - HORIZON III

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Documents available

CSR-D8480C00013.pdf

Trial Results Summaries

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