Clinical trial NCT00384176: First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colorectal Cancer
Keywords: Metastatic Colorectal Cancer
RECENTIN
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-05
Enrollment: 1814
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Exclusion Criteria:

* Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib.
* Poorly controlled hypertension

Primary outcomes:
measure: Progression Free Survival
timeFrame: Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression
Secondary outcomes:
measure: Overall Survival
timeFrame: Randomisation until data cut-off
measure: Objective Response Rate
timeFrame: Up until data cut-off
measure: Duration of Response
timeFrame: Up until data cut-off date of 15/11/2007
measure: Percentage Change in Tumour Size
timeFrame: Baseline to Week 8
measure: Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)
timeFrame: Baseline through to data cut-off
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Casa Grande
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Hot Springs
country: United States
facility: Research Site
state: Arkansas
city: Palm Springs
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Fairfield
country: United States
facility: Research Site
state: Connecticut
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Bay Pines
country: United States
facility: Research Site
state: Florida
city: Fort Meyers
country: United States
facility: Research Site
state: Florida
city: Port St Lucie
country: United States
facility: Research Site
state: Florida
city: Port St. Lucie
country: United States
facility: Research Site
state: Florida
city: Galesburg
country: United States
facility: Research Site
state: Illinois
city: Park Ridge
country: United States
facility: Research Site
state: Illinois
city: Quincy
country: United States
facility: Research Site
state: Illinois
city: Layfayette
country: United States
facility: Research Site
state: Indiana
city: New Albany
country: United States
facility: Research Site
state: Indiana
city: Alexandria
country: United States
facility: Research Site
state: Louisiana
city: Layfayette
country: United States
facility: Research Site
state: Louisiana
city: Hagerstown
country: United States
facility: Research Site
state: Maryland
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Ypsilanti
country: United States
facility: Research Site
state: Michigan
city: St Louis
country: United States
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state: Missouri
city: Great Falls
country: United States
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state: Montana
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Summit
country: United States
facility: Research Site
state: New Jersey
city: Fresh Meadows
country: United States
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state: New York
city: Northport
country: United States
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state: New York
city: Rochester
country: United States
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state: New York
city: Fayetteville
country: United States
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state: North Carolina
city: New Bern
country: United States
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state: North Carolina
city: Bismarck
country: United States
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state: North Dakota
city: Cincinnati
country: United States
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state: Ohio
city: Middletown
country: United States
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state: Ohio
city: Zanesville
country: United States
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state: Ohio
city: Coos Bay
country: United States
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state: Oregon
city: Hilton Head Island
country: United States
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state: South Carolina
city: Chattanooga
country: United States
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state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Austin
country: United States
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state: Texas
city: White River Junction
country: United States
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state: Vermont
city: Abingdon
country: United States
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state: Virginia
city: Alexandria
country: United States
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state: Virginia
city: Armidale
country: Australia
facility: Research Site
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Research Site
state: New South Wales
city: Darlinghurst
country: Australia
facility: Research Site
state: New South Wales
city: Hornsby
country: Australia
facility: Research Site
state: New South Wales
city: Kogarah
country: Australia
facility: Research Site
state: New South Wales
city: Port Macquarie
country: Australia
facility: Research Site
state: New South Wales
city: Randwick
country: Australia
facility: Research Site
state: New South Wales
city: St. Leonards
country: Australia
facility: Research Site
state: New South Wales
city: Tamworth
country: Australia
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state: New South Wales
city: Waratah
country: Australia
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state: New South Wales
city: South Brisbane
country: Australia
facility: Research Site
state: Queensland
city: Ashford
country: Australia
facility: Research Site
state: South Australia
city: Bedford Park
country: Australia
facility: Research Site
state: South Australia
city: Woodville South
country: Australia
facility: Research Site
state: South Australia
city: Hobart
country: Australia
facility: Research Site
state: Tasmania
city: Epping
country: Australia
facility: Research Site
state: Victoria
city: Ashford
country: Australia
facility: Research Site
city: Bedford Park
country: Australia
facility: Research Site
city: Bendigo
country: Australia
facility: Research Site
city: Box Hill
country: Australia
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city: Camperdown
country: Australia
facility: Research Site
city: Coffs Harbour
country: Australia
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city: Darlinghurst
country: Australia
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city: East-Melbourne
country: Australia
facility: Research Site
city: Epping
country: Australia
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city: Herston
country: Australia
facility: Research Site
city: Hobart
country: Australia
facility: Research Site
city: Hornsby
country: Australia
facility: Research Site
city: Kogarah
country: Australia
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city: Lismore
country: Australia
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city: Malvern
country: Australia
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city: Nedlands
country: Australia
facility: Research Site
city: Port Macquarie
country: Australia
facility: Research Site
city: Randwick
country: Australia
facility: Research Site
city: South Brisbane
country: Australia
facility: Research Site
city: St. Leonards
country: Australia
facility: Research Site
city: Tamworth
country: Australia
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city: Waratah
country: Australia
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city: Wodonga
country: Australia
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city: Woodville South
country: Australia
facility: Research Site
city: Kundratstrasse 3
country: Austria
facility: Research Site
state: Vienna
city: Innsbruck
country: Austria
facility: Research Site
city: Kundratstrasse 3
country: Austria
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city: Salzburg
country: Austria
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city: Wels
country: Austria
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city: Wien
country: Austria
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city: Zams
country: Austria
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Brussels (woluwe-st-lambert)
country: Belgium
facility: Research Site
city: Brussels (Woluwé-St-Lambert)
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
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city: Gent
country: Belgium
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city: Ghent
country: Belgium
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city: Kortrijk
country: Belgium
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city: Leuven
country: Belgium
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city: Roeselare
country: Belgium
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city: Calgary
country: Canada
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state: Alberta
city: Edmonton
country: Canada
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state: Alberta
city: Surrey
country: Canada
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state: British Columbia
city: Vancouver
country: Canada
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state: British Columbia
city: Sydney
country: Canada
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state: Nova Scotia
city: Barrie
country: Canada
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state: Ontario
city: Newmarket
country: Canada
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state: Ontario
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
city: St Catharines
country: Canada
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state: Ontario
city: Sudbury
country: Canada
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state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: York
country: Canada
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state: Ontario
city: Levis
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
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state: Quebec
city: Montreal
country: Canada
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city: Quebec
country: Canada
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Chomutov
country: Czech Republic
facility: Research Site
city: Kutna Hora
country: Czech Republic
facility: Research Site
city: Nova Ves pod Plesi
country: Czech Republic
facility: Research Site
city: Pardubice
country: Czech Republic
facility: Research Site
city: Tabor
country: Czech Republic
facility: Research Site
city: Alexandria
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Tampere
country: Finland
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city: Turku
country: Finland
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city: Vaasa
country: Finland
facility: Research Site
city: Boulogne Cedex
country: France
facility: Research Site
city: La Roche S YON
country: France
facility: Research Site
city: Marseille Cedex 08
country: France
facility: Research Site
city: Nantes,
country: France
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city: Nantes
country: France
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city: Paris Cedex 15
country: France
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city: Paris
country: France
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city: Saint Gregoire
country: France
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Essen
country: Germany
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city: Freiburg
country: Germany
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city: Halle
country: Germany
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city: Hannover
country: Germany
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city: Heidelberg
country: Germany
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city: Munchen
country: Germany
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city: München
country: Germany
facility: Research Site
city: Neu-isenburg
country: Germany
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city: Tubingen
country: Germany
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city: Tübingen
country: Germany
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city: Budapest
country: Hungary
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city: Debrecen
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
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city: Pécs
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Tatabanya
country: Hungary
facility: Research Site
city: Tatabánya
country: Hungary
facility: Research Site
city: Bhopal
country: India
facility: Research Site
state: Madhya Pradesh
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Varanasi
country: India
facility: Research Site
state: Uttar Prad
city: Kolkata
country: India
facility: Research Site
state: W Bengal
city: Bangalore
country: India
facility: Research Site
city: Bhopal
country: India
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Jaipur
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Pune
country: India
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city: Sheikhpura
country: India
facility: Research Site
city: Holon
country: Israel
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city: Kfar-saba
country: Israel
facility: Research Site
city: Petah Tikva
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Tel-Hashomer
country: Israel
facility: Research Site
city: Tiberias
country: Israel
facility: Research Site
city: Tzrifin
country: Israel
facility: Research Site
city: Genova
country: Italy
facility: Research Site
state: GE
city: Rozzano
country: Italy
facility: Research Site
state: MI
city: Ancona
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Floriana
country: Malta
facility: Research Site
city: Valletta
country: Malta
facility: Research Site
city: Cebu City
country: Philippines
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city: Davao City
country: Philippines
facility: Research Site
city: Molo
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Elblag
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Krakow
country: Poland
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city: Kraków
country: Poland
facility: Research Site
city: Lublin
country: Poland
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city: Poznan
country: Poland
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city: Poznań
country: Poland
facility: Research Site
city: Rybnik
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tumen
country: Russian Federation
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Lyttelton Manor
country: South Africa
facility: Research Site
city: Polokwane
country: South Africa
facility: Research Site
city: Port Elizabeth
country: South Africa
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city: Pretoria
country: South Africa
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
state: Andalucia
city: Zaragoza
country: Spain
facility: Research Site
state: Aragon
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Granollers
country: Spain
facility: Research Site
state: Cataluna
city: Hospitalet de Llobregat(barcel
country: Spain
facility: Research Site
state: Cataluna
city: Terrassa(barcelona)
country: Spain
facility: Research Site
state: Cataluna
city: Madrid
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: A Coruna
country: Spain
facility: Research Site
state: Galicia
city: A Coruña
country: Spain
facility: Research Site
city: Córdoba
country: Spain
facility: Research Site
city: Granollers
country: Spain
facility: Research Site
city: Hospitalet de Llobregat(Barcel
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Manresa
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Tao-yuan
country: Taiwan
facility: Research Site
city: Nakhonratchasima
country: Thailand
facility: Research Site
state: Naimuang
city: Chiang Mai
country: Thailand
facility: Research Site
city: Rachathewi
country: Thailand
facility: Research Site
city: Songkla
country: Thailand
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
state: Goztepe
city: Ankara
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Cherkassy
country: Ukraine
facility: Research Site
city: Chernigiv
country: Ukraine
facility: Research Site
city: Chernivtsi
country: Ukraine
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkov
country: Ukraine
facility: Research Site
city: Kherson
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lugansk
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Simferopol
country: Ukraine
facility: Research Site
city: Sumy
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Ternopol
country: Ukraine
facility: Research Site
city: Uzhgorod
country: Ukraine
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
state: Hampshire
city: Maidstone
country: United Kingdom
facility: Research Site
state: Kent
city: Northwood
country: United Kingdom
facility: Research Site
state: Middlesex
city: Sutton
country: United Kingdom
facility: Research Site
state: Surrey
city: Bebington
country: United Kingdom
facility: Research Site
city: Bournemouth
country: United Kingdom
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Guildford
country: United Kingdom
facility: Research Site
city: Ipswich
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Maidstone
country: United Kingdom
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
city: Newcastle-upon-tyne
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Poole
country: United Kingdom
facility: Research Site
city: Stockport
country: United Kingdom
facility: Research Site
city: Sutton
country: United Kingdom
facility: Research Site
city: Hanoi city
country: Vietnam
facility: Research Site
city: Ho Chi Minh city
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jane Robertson
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.