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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
Eudract Number 2005-003440-66
Secondary ID [2] 0 0
D8480C00013
Universal Trial Number (UTN)
Trial acronym
HORIZON III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival - 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.
Timepoint [1] 0 0
Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression
Secondary outcome [1] 0 0
Overall Survival - Number of months from randomisation to the date of death from any cause
Timepoint [1] 0 0
Randomisation until data cut-off
Secondary outcome [2] 0 0
Objective Response Rate - 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.
Timepoint [2] 0 0
Up until data cut-off
Secondary outcome [3] 0 0
Duration of Response - 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.
Timepoint [3] 0 0
Up until data cut-off date of 15/11/2007
Secondary outcome [4] 0 0
Percentage Change in Tumour Size - Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100
Timepoint [4] 0 0
Baseline to Week 8
Secondary outcome [5] 0 0
Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI) - 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.
Timepoint [5] 0 0
Baseline through to data cut-off

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.
Minimum age
18 Years
Maximum age
130 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib.

- Poorly controlled hypertension

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Research Site - Armidale
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Research Site - Coffs Harbour
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Research Site - St. Leonards
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Research Site - Tamworth
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Research Site - South Brisbane
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Research Site - Bedford Park
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Research Site - Woodville South
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Research Site - Malvern
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Research Site - Wodonga
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- Armidale
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- Coffs Harbour
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- Darlinghurst
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- Hornsby
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- Kogarah
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- Port Macquarie
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- Randwick
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- St. Leonards
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- Tamworth
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- Waratah
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- South Brisbane
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- Ashford
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- Bedford Park
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- Woodville South
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- Hobart
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- Epping
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- Bendigo
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- Box Hill
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- Camperdown
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- East-Melbourne
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- Herston
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- Lismore
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- Malvern
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- Nedlands
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- Wodonga
Recruitment outside Australia
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Michigan
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Innsbruck
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Kundratstrasse 3
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Country [200] 0 0
United Kingdom
State/province [200] 0 0
Maidstone
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Newcastle Upon Tyne
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Newcastle-upon-tyne
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Northwood
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Poole
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Stockport
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Sutton
Country [207] 0 0
Vietnam
State/province [207] 0 0
Hanoi city
Country [208] 0 0
Vietnam
State/province [208] 0 0
Ho Chi Minh city
Country [209] 0 0
Vietnam
State/province [209] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00384176
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jane Robertson
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications