Colon carcinoma MedDRA version: 6.1 Level: PT Classification code 10061045
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Radically operated Stage III colon carcinoma . Age or 70 years. PS 0 or 1. Absence of preexisting peripheral neuropathy. Adequate liver and kidney functionality. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Metastatic colon carcinoma . PS 1. Creatinin clearance 30 . Blood bilirubin 1,5 times the normal level. Neuropaty of any degree and origin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Valuation of dose intensity. Valuation of kind and seriousness of the side effects.;Secondary Objective: Valuation of desease free survival.;Primary end point(s): Valuation of dose intensity. Valuation of kind and seriousness of the side effects. | — |
Countries
Italy