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MULTICENTER INTERNATIONAL RANDOMIZED PHASE III STUDY OF 5-FU/LV OXALIPLATIN IN THE ADJUVANT TREATMENT OF COLONUnique Dataset IDColorec_SanofiU_1998_128
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).
Datasets contain de-identified subjects from the comparator arm. Demographic, baseline information, safety, efficacy datasets, medication, and dosing datasets were included amongst others.
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.
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.
To gain access to the data and analytic tools click here.
DATA DICTIONARY: sanofi_SR96669_EFC3313_data_definition.xls
DATA (COMPARATOR ARM): sanofi_SR96669_efc3313_datasets_readme.zip