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Colorectal

MULTICENTER INTERNATIONAL RANDOMIZED PHASE III STUDY OF 5-FU/LV OXALIPLATIN IN THE ADJUVANT TREATMENT OF COLON

Unique Data Set IDColorec_SanofiU_1998_128
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients2246Comparator (Control) Arm Enrolled Patients1122RandomizationYesClinicalTrial.gov IDNCT00275210ClinicalTrial.gov URLhttps://clinicaltrials.gov/show/NCT00275210
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeADS

Clinical Trial Title

MULTICENTER INTERNATIONAL RANDOMIZED PHASE III STUDY OF 5-FU/LV OXALIPLATIN IN THE ADJUVANT TREATMENT OF COLON

Trial Summary and Conditions

Multicenter, international, open-label, randomized study comparing 2 treatment regimens (FOLFOX4 versus LV5FU2) as adjuvant treatment of Dukes stage B2-C colon cancer. The minimization method was used in order to balance treatment allocation according to the following stratification factors: center, extent of invasion of the primary tumor through the wall of the colon and tumor adherence (T1, T2, T3, T4), number of involved lymph nodes (N0, N1, N2), bowel obstruction (present, absent) and tumor perforation (present, absent).

Data Summary

Datasets contain de-identified subjects from the comparator arm. Demographic, baseline information, safety, efficacy datasets, medication, and dosing datasets were included amongst others.

Study Objectives

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.

Outcome Measures

The primary efficacy endpoint was DFS, defined as the time from the randomization date until the earlier of death or evidence of disease relapse. The secondary endpoint was OS defined as the time from the randomization date until death from any cause.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: sanofi_SR96669_EFC3313_protocol_Redacted.pdf

CRF: sanofi_SR96669_EFC3313_CRF_redacted.pdf

DATA DICTIONARY: sanofi_SR96669_EFC3313_data_definition.xls

DATA (COMPARATOR ARM): sanofi_SR96669_efc3313_datasets_readme.zip