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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
April 2003
NCT00275210Uploaded 04-25-2015
Available for Download
PDS UID: Colorec_SanofiU_1998_128
Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
Provider Information
Provider Data Description Primary objective: To compare Arm A (FOLFOX4): Oxaliplatin+LV5FU2 to Arm B: LV5FU2 in terms of disease-free survival (DFS). Secondary objective: To compare Arms A and B in terms of overall survival (OS) and to evaluate the safety profile in both arms.
SponsorSanofi US Services Inc.
Data ProviderSanofi
Partial set or SubsetOriginal Data
Patients in dataset2246
# of Patients Control1122
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/fm7n-cw30
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryTo evaluate the FOLFOX regimen versus LV5FU2 in the adjuvant treatment of stage II and III colon cancer. Primary objective: Disease Free Survival (DFS) Secondary objective: Overall Survival (OS), safety (including long term toxicity)
ConditionsColonic Neoplasms
Intervention TypeDrug: Oxaliplatin (SR96669)
Drug(s)N/A
Total Enrolled2246
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionN/A
Secondary IDN/A
PubMed (PMID)15175436
36306483
36227604
33356421
32085892
31296923
26527776
22915656
Collaborator(s)N/A
Region(s)Australia
Austria
Belgium
Denmark
France
Germany
Greece
Hungary
Israel
Italy
Netherlands
Norway
Poland
Portugal
Singapore
Spain
Sweden
Switzerland
United Kingdom
Age Range18 Years to 75 Years (Adult, Older Adult)
Files:
PROTOCOLsanofi_SR96669_EFC3313_protocol_Redacted.pdf
CRFsanofi_SR96669_EFC3313_CRF_redacted.pdf
DATA DICTIONARYsanofi_SR96669_EFC3313_data_definition.xls
DATA (COMPARATOR ARM)sanofi_SR96669_efc3313_datasets_readme.zip
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