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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
Recruitment hospital [6] 0 0
Research Site - Port Macquarie
Recruitment hospital [7] 0 0
Research Site - Randwick
Recruitment hospital [8] 0 0
Research Site - St. Leonards
Recruitment hospital [9] 0 0
Research Site - Tamworth
Recruitment hospital [10] 0 0
Research Site - Waratah
Recruitment hospital [11] 0 0
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
Recruitment hospital [24] 0 0
Research Site - Nedlands
Recruitment hospital [25] 0 0
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
Recruitment postcode(s) [23] 0 0
- Malvern
Recruitment postcode(s) [24] 0 0
- Nedlands
Recruitment postcode(s) [25] 0 0
- Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Michigan
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New Jersey
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Innsbruck
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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
Trial website
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

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