metastatic colorectal cancer
Conditions
Brief summary
ORR by 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
1. PFS defined as the time from random assignment in the clinical trial to disease progression or death from any cause., 2. OS defined as the interval from enrollment to death for every cause., 3. The safety profile of the trial drugs as measured by the incidence of AEs evaluated using the NCI- CTCAE version 5.0 (CTCAE v 5.0), SAEs, clinical laboratory assessments, vital signs, physical examination, ECG parameters, and ECOG PS, 4. Quality of life (QoL) questionnaire (EORTC QLQ-C30)
Interventions
Sponsors
Gruppo Oncologico Dell'Italia Meridionale
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR by 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 |
|---|---|
| 1. PFS defined as the time from random assignment in the clinical trial to disease progression or death from any cause., 2. OS defined as the interval from enrollment to death for every cause., 3. The safety profile of the trial drugs as measured by the incidence of AEs evaluated using the NCI- CTCAE version 5.0 (CTCAE v 5.0), SAEs, clinical laboratory assessments, vital signs, physical examination, ECG parameters, and ECOG PS, 4. Quality of life (QoL) questionnaire (EORTC QLQ-C30) | — |
Countries
Italy
Outcome results
None listed