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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
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
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
Timepoint [1] 0 0
Randomisation until data cut-off
Secondary outcome [2] 0 0
Objective Response Rate
Timepoint [2] 0 0
Up until data cut-off
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
Up until data cut-off date of 15/11/2007
Secondary outcome [4] 0 0
Percentage Change in Tumour Size
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)
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
Sex
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
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
30/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2015
Sample size
Target
Accrual to date
Final
1814
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Research Site - Armidale
Recruitment hospital [2] 0 0
Research Site - Coffs Harbour
Recruitment hospital [3] 0 0
Research Site - Darlinghurst
Recruitment hospital [4] 0 0
Research Site - Hornsby
Recruitment hospital [5] 0 0
Research Site - Kogarah
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Research Site - Port Macquarie
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Research Site - Randwick
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Research Site - St. Leonards
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Research Site - Tamworth
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Research Site - Waratah
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Research Site - South Brisbane
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Research Site - Ashford
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Research Site - Bedford Park
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Research Site - Woodville South
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Research Site - Hobart
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Research Site - Epping
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Research Site - Bendigo
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Research Site - Box Hill
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Research Site - Camperdown
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Research Site - East-Melbourne
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Research Site - Herston
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Research Site - Lismore
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Research Site - Malvern
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Research Site - Nedlands
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Research Site - Wodonga
Recruitment postcode(s) [1] 0 0
- 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
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Michigan
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Missouri
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Montana
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Nebraska
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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South Carolina
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Tennessee
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Texas
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Vermont
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Vienna
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Innsbruck
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Kundratstrasse 3
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Salzburg
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Wels
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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/study/NCT00384176
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00384176