Adjuvant chemotherapy in stage III colon carcinoma in patients age or 70 years. Feasibility of CAPOX scheme oxaliplatin 70 mg/mq days 1-8 and capecitabine 1000 mg/mq X 2 die days 1-14 every 21 days for 6 cycles - ND
- Conditions
- Colon carcinomaMedDRA version: 6.1Level: PTClassification code 10061045
- Registration Number
- EUCTR2006-000267-29-IT
- Lead Sponsor
- Centro sociale oncologico
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
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
Metastatic colon carcinoma . PS 1. Creatinin clearance 30 . Blood bilirubin 1,5 times the normal level. Neuropaty of any degree and origin.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method