First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX
HORIZON III
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
2 other identifiers
interventional
1,814
27 countries
273
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Aug 2006
Longer than P75 for phase_2 colorectal-cancer
273 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 30, 2006
CompletedFirst Submitted
Initial submission to the registry
October 3, 2006
CompletedFirst Posted
Study publicly available on registry
October 5, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2009
CompletedResults Posted
Study results publicly available
November 28, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2015
CompletedApril 14, 2017
April 1, 2017
3.2 years
October 3, 2006
March 7, 2012
April 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression
Secondary Outcomes (5)
Overall Survival
Randomisation until data cut-off
Objective Response Rate
Up until data cut-off
Duration of Response
Up until data cut-off date of 15/11/2007
Percentage Change in Tumour Size
Baseline to Week 8
Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)
Baseline through to data cut-off
Study Arms (2)
1
ACTIVE COMPARATORBevacizumab + FOLFOX
2
EXPERIMENTALCediranib + FOLFOX
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib.
- Poorly controlled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (280)
Research Site
Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Casa Grande, Arizona, United States
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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Palm Springs, California, United States
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San Diego, California, United States
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Fairfield, Connecticut, United States
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Stamford, Connecticut, United States
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Bay Pines, Florida, United States
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Fort Meyers, Florida, United States
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Port Saint Lucie, Florida, United States
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Galesburg, Illinois, United States
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Park Ridge, Illinois, United States
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Quincy, Illinois, United States
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Layfayette, Indiana, United States
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New Albany, Indiana, United States
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Alexandria, Louisiana, United States
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Layfayette, Louisiana, United States
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Hagerstown, Maryland, United States
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Ann Arbor, Michigan, United States
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Ypsilanti, Michigan, United States
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St Louis, Missouri, United States
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Great Falls, Montana, United States
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Lincoln, Nebraska, United States
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Summit, New Jersey, United States
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Fresh Meadows, New York, United States
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Northport, New York, United States
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Rochester, New York, United States
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Fayetteville, North Carolina, United States
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New Bern, North Carolina, United States
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Bismarck, North Dakota, United States
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Cincinnati, Ohio, United States
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Middletown, Ohio, United States
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Zanesville, Ohio, United States
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Coos Bay, Oregon, United States
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Hilton Head Island, South Carolina, United States
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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White River Junction, Vermont, United States
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Abingdon, Virginia, United States
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Alexandria, Virginia, United States
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Armidale, New South Wales, Australia
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Coffs Harbour, New South Wales, Australia
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Darlinghurst, New South Wales, Australia
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Hornsby, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Port Macquarie, New South Wales, Australia
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Randwick, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Tamworth, New South Wales, Australia
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Waratah, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Ashford, South Australia, Australia
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Bedford Park, South Australia, Australia
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Woodville South, South Australia, Australia
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Hobart, Tasmania, Australia
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Epping, Victoria, Australia
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Ashford, Australia
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Bedford Park, Australia
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Bendigo, Australia
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Box Hill, Australia
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Camperdown, Australia
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Coffs Harbour, Australia
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Darlinghurst, Australia
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East Melbourne, Australia
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Epping, Australia
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Herston, Australia
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Hobart, Australia
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Hornsby, Australia
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Kogarah, Australia
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Lismore, Australia
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Malvern, Australia
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Nedlands, Australia
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Port Macquarie, Australia
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Randwick, Australia
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South Brisbane, Australia
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St Leonards, Australia
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Tamworth, Australia
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Waratah, Australia
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Wodonga, Australia
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Woodville South, Australia
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Kundratstrasse 3, Vienna, Austria
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Innsbruck, Austria
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Kundratstrasse 3, Austria
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Salzburg, Austria
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Vienna, Austria
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Wels, Austria
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Zams, Austria
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Bonheiden, Belgium, Belgium
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Brussels (woluwe-st-lambert), Belgium, Belgium
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Edegem, Belgium, Belgium
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Ghent, Belgium, Belgium
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Kortrijk, Belgium, Belgium
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Leuven, Belgium, Belgium
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Roeselare, Belgium, Belgium
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Bonheiden, Belgium
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Bruges, Belgium
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Brussels (Woluwé-St-Lambert), Belgium
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Edegem, Belgium
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Ghent, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Roeselare, Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Sydney, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Newmarket, Ontario, Canada
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Scarborough Village, Ontario, Canada
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St. Catharines, Ontario, Canada
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Toronto, Ontario, Canada
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York, Ontario, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Montreal, Canada
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Brno, Czechia
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Chomutov, Czechia
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Kutná Hora, Czechia
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Nová Ves pod Pleší, Czechia
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Pardubice, Czechia
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Tábor, Czechia
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Alexandria, Egypt
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Cairo, Egypt
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Helsinki, Finland
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Tampere, Finland
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Turku, Finland
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Vaasa, Finland
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Boulogne, France
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La Roche S YON, France
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Marseille, France
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Nantes, France
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Paris, France
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Saint-Grégoire, France
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Dresden, Germany
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Essen, Germany
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Freiburg im Breisgau, Germany
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Halle, Germany
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Hanover, Germany
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Heidelberg, Germany
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München, Germany
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Neu-Isenburg, Germany
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Tübingen, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Tatabánya, Hungary
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Bhopal, Madhya Pradesh, India
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Pune, Maharashtra, India
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Jaipur, Rajasthan, India
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Varanasi, Uttar Prad, India
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Kolkata, West Bengal, India
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Bangalore, India
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Bhopal, India
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Chennai, India
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Hyderabad, India
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Jaipur, India
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Kolkata, India
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Mumbai, India
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Pune, India
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Sheikhpura, India
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Holon, Israel
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Kfar Saba, Israel
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Petah Tikva, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Tiberias, Israel
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Tzrifin, Israel
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Genova, GE, Italy
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Rozzano, MI, Italy
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Roma, Roma, Italy
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Ancona, Italy
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Genova, Italy
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Napoli, Italy
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Roma, Italy
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Rozzano, Italy
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Riga, Latvia
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Floriana, Malta
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Valletta, Malta
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Cebu City, Philippines
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Davao City, Philippines
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Molo, Philippines
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Quezon City, Philippines
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Bytom, Poland
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Elblag, Poland
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Gdynia, Poland
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Krakow, Poland
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Lublin, Poland
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Poznan, Poland
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Rybnik, Poland
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Warsaw, Poland
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Barnaul, Russia
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Novosibirsk, Russia
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Omsk, Russia
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Tomsk, Russia
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Tyumen, Russia
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Bratislava, Slovakia
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Košice, Slovakia
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Nitra, Slovakia
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Prešov, Slovakia
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Lyttelton Manor, South Africa, South Africa
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Cape Town, South Africa
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Polokwane, South Africa
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Port Elizabeth, South Africa
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Pretoria, South Africa
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Córdoba, Andalusia, Spain
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Zaragoza, Aragon, Spain
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Barcelona, Catalonia, Spain
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Granollers, Catalonia, Spain
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Hospitalet de Llobregat(barcel, Catalonia, Spain
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Terrassa(barcelona), Catalonia, Spain
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A Coruña, Galicia, Spain
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Madrid, Madrid, Spain
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Oviedo, Principality of Asturias, Spain
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Valencia, Valencia, Spain
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A Coruña, Spain
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Córdoba, Spain
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Granollers, Spain
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Hospitalet de Llobregat(Barcel, Spain
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Madrid, Spain
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Manresa, Spain
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Oviedo, Spain
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Valencia, Spain
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Zaragoza, Spain
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Taoyuan District, Taiwan, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Nakhonratchasima, Naimuang, Thailand
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Chiang Mai, Thailand, Thailand
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Songkhla, Thailand, Thailand
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Chiang Mai, Thailand
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Rachathewi, Thailand
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Songkhla, Thailand
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Istanbul, Goztepe, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Cherkassy, Ukraine
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Chernihiv, Ukraine
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Chernivtsi, Ukraine
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kherson, Ukraine
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Kiev, Ukraine
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Kyiv, Ukraine
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Luhansk, Ukraine
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Lviv, Ukraine
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Poltava, Ukraine
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Simferopol, Ukraine
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Sumy, Ukraine
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Ternopil, Ukraine
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Uzhhorod, Ukraine
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Southampton, Hampshire, United Kingdom
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Maidstone, Kent, United Kingdom
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Northwood, Middlesex, United Kingdom
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Sutton, Surrey, United Kingdom
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Bebington, United Kingdom
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Bournemouth, United Kingdom
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Bradford, United Kingdom
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Guildford, United Kingdom
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Ipswich, United Kingdom
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London, United Kingdom
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Maidstone, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Northwood, United Kingdom
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Poole, United Kingdom
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Stockport, United Kingdom
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Sutton, United Kingdom
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Hanoi, Vietnam, Vietnam
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Ho Chi Minh City, Vietnam, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
Related Publications (3)
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.
PMID: 31378656DERIVEDAbdel-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.
PMID: 30679026DERIVEDRobertson 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.
PMID: 19203899DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Jane Robertson
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2006
First Posted
October 5, 2006
Study Start
August 30, 2006
Primary Completion
November 15, 2009
Study Completion
August 19, 2015
Last Updated
April 14, 2017
Results First Posted
November 28, 2012
Record last verified: 2017-04