Patients with histologically confirmed metastatic colorectal cancer progressed after a first line treatment containing FOLFIRI and BEV. MedDRA version: 9.1 Level: LLT Classification code 10061045 Term: Colon neoplasm
Conditions
Interventions
Trade Name: OXALIPLATINO MAY*INF FL 100MG
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Oxaliplatin
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Conce
Sponsors
GISCAD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:  Age >18 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:  History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications  Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)  History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake  Known grade 3 or 4 allergic reaction to any of the components of the treatment  Known drug abuse/ alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: overall survival;Secondary Objective:  Progression free survival  Quality of life, evaluated by means a VAS scale  Health resource utilisation and economic evaluation  Toxicity and incidence of adverse events;Primary end point(s): ACTIVITY TOXICITY QUALITY of LIFE | — |
Countries
Italy
Outcome results
None listed