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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00384176
Registration number
NCT00384176
Ethics application status
Date submitted
3/10/2006
Date registered
5/10/2006
Date last updated
14/04/2017
Titles & IDs
Public title
First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX
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Scientific title
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
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Secondary ID [1]
0
0
Eudract Number 2005-003440-66
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Secondary ID [2]
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0
D8480C00013
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Universal Trial Number (UTN)
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Trial acronym
HORIZON III
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
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0
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Condition category
Condition code
Cancer
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0
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cediranib
Treatment: Drugs - Bevacizumab
Treatment: Drugs - 5-fluorouracil ( in FOLFOX)
Treatment: Drugs - Leucovorin (in FOLFOX)
Treatment: Drugs - Oxaliplatin (in FOLFOX)
Active comparator: 1 - Bevacizumab + FOLFOX
Experimental: 2 - Cediranib + FOLFOX
Treatment: Drugs: Cediranib
oral tablet once daily
Treatment: Drugs: Bevacizumab
intravenous infusion
Treatment: Drugs: 5-fluorouracil ( in FOLFOX)
intravenous infusion
Treatment: Drugs: Leucovorin (in FOLFOX)
intravenous infusion
Treatment: Drugs: Oxaliplatin (in FOLFOX)
intravenous infusion
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival
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Assessment method [1]
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0
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.
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Timepoint [1]
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Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression
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Secondary outcome [1]
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Overall Survival
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Assessment method [1]
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Number of months from randomisation to the date of death from any cause
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Timepoint [1]
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Randomisation until data cut-off
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Secondary outcome [2]
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Objective Response Rate
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Assessment method [2]
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0
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.
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Timepoint [2]
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0
Up until data cut-off
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Secondary outcome [3]
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0
Duration of Response
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Assessment method [3]
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0
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.
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Timepoint [3]
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0
Up until data cut-off date of 15/11/2007
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Secondary outcome [4]
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Percentage Change in Tumour Size
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Assessment method [4]
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Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)\*100
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Timepoint [4]
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0
Baseline to Week 8
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Secondary outcome [5]
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0
Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline through to data cut-off
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Eligibility
Key inclusion criteria
* Clinical Diagnosis of colon or rectal cancer
* No prior systemic therapy for metastatic disease. Any adjuvant/neoadjuvant oxaliplatin therapy must have been received >12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received >6 months prior to study entry.
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib.
* Poorly controlled hypertension
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/08/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/08/2015
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Sample size
Target
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Accrual to date
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Final
1814
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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Research Site - Armidale
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Recruitment hospital [2]
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Research Site - Coffs Harbour
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Recruitment hospital [3]
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0
Research Site - Darlinghurst
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Recruitment hospital [4]
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0
Research Site - Hornsby
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Recruitment hospital [5]
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0
Research Site - Kogarah
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Recruitment hospital [6]
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Research Site - Port Macquarie
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Recruitment hospital [7]
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Research Site - Randwick
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Recruitment hospital [8]
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Research Site - St. Leonards
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Recruitment hospital [9]
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Research Site - Tamworth
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Recruitment hospital [10]
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Research Site - Waratah
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Recruitment hospital [11]
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Research Site - South Brisbane
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Recruitment hospital [12]
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Research Site - Ashford
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Recruitment hospital [13]
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Research Site - Bedford Park
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Recruitment hospital [14]
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0
Research Site - Woodville South
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Research Site - Hobart
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Recruitment hospital [16]
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Research Site - Epping
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Recruitment hospital [17]
0
0
Research Site - Bendigo
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Recruitment hospital [18]
0
0
Research Site - Box Hill
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Recruitment hospital [19]
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Research Site - Camperdown
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Research Site - East-Melbourne
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Recruitment hospital [21]
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Research Site - Herston
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Recruitment hospital [22]
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Research Site - Lismore
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Recruitment hospital [23]
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Research Site - Malvern
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Recruitment hospital [24]
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Research Site - Nedlands
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Recruitment hospital [25]
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Research Site - Wodonga
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Recruitment postcode(s) [1]
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- Armidale
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Recruitment postcode(s) [2]
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- Coffs Harbour
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Recruitment postcode(s) [3]
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- Darlinghurst
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Recruitment postcode(s) [4]
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- Hornsby
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Recruitment postcode(s) [5]
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- Kogarah
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Recruitment postcode(s) [6]
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- Port Macquarie
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Recruitment postcode(s) [7]
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- Randwick
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Recruitment postcode(s) [8]
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- St. Leonards
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Recruitment postcode(s) [9]
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- Tamworth
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Recruitment postcode(s) [10]
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- Waratah
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Recruitment postcode(s) [11]
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- South Brisbane
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Recruitment postcode(s) [12]
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- Ashford
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Recruitment postcode(s) [13]
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- Bedford Park
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Recruitment postcode(s) [14]
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- Woodville South
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Recruitment postcode(s) [15]
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0
- Hobart
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Recruitment postcode(s) [16]
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0
- Epping
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Recruitment postcode(s) [17]
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- Bendigo
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Recruitment postcode(s) [18]
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0
- Box Hill
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Recruitment postcode(s) [19]
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0
- Camperdown
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Recruitment postcode(s) [20]
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0
- East-Melbourne
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Recruitment postcode(s) [21]
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0
- Herston
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Recruitment postcode(s) [22]
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0
- Lismore
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Recruitment postcode(s) [23]
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0
- Malvern
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Recruitment postcode(s) [24]
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0
- Nedlands
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Recruitment postcode(s) [25]
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0
- Wodonga
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Alabama
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0
United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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0
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California
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United States of America
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0
Connecticut
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0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Illinois
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Indiana
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0
United States of America
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State/province [9]
0
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Louisiana
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United States of America
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State/province [10]
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Maryland
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United States of America
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State/province [11]
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Michigan
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United States of America
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State/province [12]
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Missouri
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United States of America
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State/province [13]
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Montana
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0
0
United States of America
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State/province [14]
0
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Nebraska
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0
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United States of America
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State/province [15]
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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North Dakota
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United States of America
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Ohio
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United States of America
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State/province [20]
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Oregon
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United States of America
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State/province [21]
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Vermont
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United States of America
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Virginia
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Austria
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Vienna
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Austria
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Innsbruck
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Austria
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State/province [28]
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Kundratstrasse 3
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Austria
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Salzburg
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Austria
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Wels
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0
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Austria
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Wien
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0
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Austria
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State/province [32]
0
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Zams
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Belgium
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Bonheiden
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Belgium
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Brugge
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Belgium
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Brussels (woluwe-st-lambert)
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Belgium
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Brussels (Woluwé-St-Lambert)
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Ghent
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Roeselare
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Montreal
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Czech Republic
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Brno
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Czech Republic
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Chomutov
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Czech Republic
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Kutna Hora
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Czech Republic
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Nova Ves pod Plesi
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Pardubice
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Czech Republic
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Tabor
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Egypt
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Alexandria
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Egypt
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Cairo
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Finland
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Helsinki
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Finland
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Tampere
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0
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Finland
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Turku
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Finland
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Vaasa
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France
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Boulogne Cedex
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France
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La Roche S YON
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Marseille Cedex 08
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France
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Nantes,
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France
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Nantes
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France
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Paris Cedex 15
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France
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Paris
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France
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Saint Gregoire
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Germany
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Dresden
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Halle
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Munchen
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Germany
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München
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Neu-isenburg
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Germany
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Tubingen
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Germany
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Tübingen
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Debrecen
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Szeged
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Tatabanya
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Tatabánya
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India
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Madhya Pradesh
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India
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India
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India
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India
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India
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India
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India
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India
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India
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India
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Israel
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Tel-Hashomer
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Israel
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Tiberias
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Israel
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Tzrifin
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Italy
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GE
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Italy
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MI
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Italy
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Ancona
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Italy
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Genova
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Italy
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Napoli
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Italy
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Roma
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Italy
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Rozzano
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Latvia
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Riga
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Malta
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Floriana
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Malta
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Valletta
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Philippines
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Cebu City
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Philippines
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Davao City
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Philippines
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Molo
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Philippines
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Quezon City
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Poland
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Bytom
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Poland
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Elblag
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Poland
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Gdynia
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Poland
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Krakow
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Poland
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Kraków
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Poland
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Lublin
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Poland
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Poznan
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Poland
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Rybnik
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Poland
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Warszawa
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Russian Federation
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Barnaul
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Tomsk
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Russian Federation
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Tumen
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Nitra
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Slovakia
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Presov
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South Africa
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Cape Town
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South Africa
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Lyttelton Manor
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South Africa
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Polokwane
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South Africa
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Port Elizabeth
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South Africa
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Pretoria
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Spain
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Andalucia
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Spain
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Aragon
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Spain
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Asturias
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Spain
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Cataluna
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Spain
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Comunidad de Madrid
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Spain
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Comunidad Valenciana
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Spain
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Galicia
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Spain
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A Coruña
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Spain
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Córdoba
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Spain
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Granollers
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Spain
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Hospitalet de Llobregat(Barcel
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Spain
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Madrid
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Spain
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Manresa
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Spain
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Oviedo
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Spain
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Valencia
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Spain
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Zaragoza
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Taiwan
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Taipei
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Taiwan
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Thailand
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Naimuang
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Thailand
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Chiang Mai
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Thailand
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Rachathewi
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Thailand
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Songkla
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Goztepe
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Turkey
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Ankara
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Turkey
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Izmir
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Ukraine
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Ukraine
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Ukraine
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Chernivtsi
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kharkov
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Ukraine
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Kherson
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Ukraine
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Kiev
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Ukraine
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Kyiv
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Ukraine
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Lugansk
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Ukraine
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Lviv
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Ukraine
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Poltava
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Ukraine
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Simferopol
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Ukraine
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Sumy
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Ukraine
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Ternopil
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Ukraine
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Ternopol
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Ukraine
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Uzhgorod
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United Kingdom
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Hampshire
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Kent
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Middlesex
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Surrey
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Bebington
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Bradford
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United Kingdom
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Guildford
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United Kingdom
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Ipswich
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United Kingdom
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London
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United Kingdom
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Maidstone
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Newcastle-upon-tyne
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United Kingdom
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Northwood
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United Kingdom
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Poole
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Stockport
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United Kingdom
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Sutton
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Vietnam
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Hanoi city
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Vietnam
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Ho Chi Minh city
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Vietnam
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State/province [209]
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00384176
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Trial related presentations / publications
Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15. Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28. Robertson JD, Botwood NA, Rothenberg ML, Schmoll HJ. Phase III trial of FOLFOX plus bevacizumab or cediranib (AZD2171) as first-line treatment of patients with metastatic colorectal cancer: HORIZON III. Clin Colorectal Cancer. 2009 Jan;8(1):59-60. doi: 10.3816/CCC.2009.n.010.
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Public notes
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Contacts
Principal investigator
Name
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0
Jane Robertson
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Address
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AstraZeneca
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00384176
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