metastatic colorectal cancer
Conditions
Brief summary
The Overall Response Rate (ORR) according to RECIST 1.1 defined as the proportion of patients who have a partial or complete response to therapy. An external radiology department will receive the images of radiological re-evaluations from the participating sites. The imaging will be assessed by a blind operator.
Detailed description
Progression Free Survival (PFS) according to RECIST 1.1 defined as the time from random assignment in the clinical trial to disease progression or death from any cause., The Overall Survival (OS) defined as the interval from enrollment to death for every cause., The safety profile of the trial drugs as measured by the incidence of AEs, SAEs, clinical laboratory assessments, vital signs, physical examination, ECG parameters, and ECOG PS.
Interventions
DRUGCETUXIMAB
DRUGOXALIPLATIN
DRUGFLUOROURACIL
DRUGBEVACIZUMAB
DRUGCALCIUM LEVOFOLINATE
DRUGIRINOTECAN
Sponsors
Gruppo Oncologico Dell'Italia Meridionale
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Overall Response Rate (ORR) according to RECIST 1.1 defined as the proportion of patients who have a partial or complete response to therapy. An external radiology department will receive the images of radiological re-evaluations from the participating sites. The imaging will be assessed by a blind operator. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) according to RECIST 1.1 defined as the time from random assignment in the clinical trial to disease progression or death from any cause., The Overall Survival (OS) defined as the interval from enrollment to death for every cause., The safety profile of the trial drugs as measured by the incidence of AEs, SAEs, clinical laboratory assessments, vital signs, physical examination, ECG parameters, and ECOG PS. | — |
Countries
Italy, Spain
Outcome results
None listed