Colorectal cancer patients undergoing treatment with oxaliplatine every 15 days, 5 fluoro uracile and calcium levofolinate, for adjuvant or metastatic setting will be recruited in this study. The aim of this study is to look for some genetic and proteomic predicting markers of neurotoxicity. MedDRA version: 9.1 Level: LLT Classification code 10010029 Term: Colorectal cancer NOS MedDRA version: 9.1 Level: LLT Classification code 10010034 Term: Colorectal cancer stage III MedDRA version: 9.
Conditions
Interventions
Trade Name: Eloxatine
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825943
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Conc
Sponsors
CENTRE PAUL PAPIN - IRCAM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: histologically confirmed colorectal cancer in subjects undergoing oxaliplatine, 5-fluoro uracile and lfolinic acid treatment. man or woman > 18years old life expectancy > 3 month adjuvant chemotherapy allowed no pre existing neuropathy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: neuropathy prior chemotherapy using platinum or taxane subject who is pregnant or breast feeding any investigational agent or therapy < 28 days prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Genetic and proteomic analysis of markers looking for relation to neurotoxicity and predictive value. ;Secondary Objective: Studying acute and chronique neurotoxicity.;Primary end point(s): Genetic and proteomic analysis of neurotoxicity predicting markers in Oxaliplatin treated patients. | — |
Countries
France
Outcome results
None listed