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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
November 2009
NCT00384176Uploaded 08-29-2013
Available for Download
PDS UID: Colorec_AstraZe_2006_78
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
PDS UID: Colorec_Multipl_2006_251Go to Study
Enhancing the Analytic Capacity of Colorec_AstraZe_2006_78 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionThe primary objective of the study is to determine:The efficacy of cediranib in combination with 5 fluorouracil (5 FU), leucovorin (or equivalent folinic acid preparation) and oxaliplatin (FOLFOX) compared to the efficacy of bevacizumab in combination with FOLFOX by assessment of progression free survival (PFS).The secondary objectives of the study are to determine:1. The efficacy of cediranib in combination with FOLFOX compared to the efficacy of bevacizumab in combination with FOLFOX by assessment of overall survival (OS), overall response rate (ORR; complete response [CR] + partial response [PR]) and duration of response.2. The safety and tolerability of randomised study therapies in combination with FOLFOX.3. The effects on quality of life (QoL) and disease-related symptoms of cediranib in combination with FOLFOX, compared with the effects of bevacizumab in combination with FOLFOX.
SponsorAstraZeneca
Data ProviderAstraZeneca
Partial set or SubsetOriginal Data
Patients in dataset1805
# of Patients Control690
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/3zrq-0q66
CDISC StandardSAS Reporting datasets
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe 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.
ConditionsColorectal Cancer
Intervention TypeDrug: Cediranib
Drug: Bevacizumab
Drug: 5-fluorouracil ( in FOLFOX)
Drug: Leucovorin (in FOLFOX)
Drug: Oxaliplatin (in FOLFOX)
Drug(s)Drug: Bevacizumab
Drug: 5-fluorouracil ( in FOLFOX)
Drug: Leucovorin (in FOLFOX)
Drug: Oxaliplatin (in FOLFOX)
Drug: Cediranib
Total Enrolled1814
RandomizationRandomized
Blinding MethodQuadruple
Arms Intervention1 - Active Comparator
2 - Experimental
Secondary IDEudract Number 2005-003440-66
PubMed (PMID)31378656
30679026
19203899
Collaborator(s)N/A
Region(s)United States
Australia
Austria
Belgium
Canada
Czech Republic
Egypt
Finland
France
Germany
Hungary
India
Israel
Italy
Latvia
Malta
Philippines
Poland
Russian Federation
Slovakia
South Africa
Spain
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
Vietnam
Age Range18 Years to 130 Years (Adult, Older Adult)
Files:
PROTOCOLAstraZeneca Study Protocol Cediranib.pdf
CRFAstraZeneca CRF Cediranib.pdf
DATA (COMPARATOR ARM)AstraZeneca Data Cediranib.zip
DATA (COMPARATOR ARM)AstraZeneca Data Cediranib.xls
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