METASTATIC COLORECTAL CANCER
Conditions
Brief summary
ORR is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria. The determination of clinical response will be based on investigator-reported measurements. Responses will be evaluated with a chest and abdominal computed tomography (CT) scan every 8 weeks. Patients who do not have an on-study assessment will be included in the analysis as non-responders.
Detailed description
Progression-free survival (PFS).Overall survival (OS).Toxicity rate.Quality of Life (QoL) is
Interventions
DRUGVINORELBINE
DRUGVinorelbine 30 mg soft capsules
Sponsors
I.F.O. Istituti Fisioterapici Ospitalieri
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria. The determination of clinical response will be based on investigator-reported measurements. Responses will be evaluated with a chest and abdominal computed tomography (CT) scan every 8 weeks. Patients who do not have an on-study assessment will be included in the analysis as non-responders. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS).Overall survival (OS).Toxicity rate.Quality of Life (QoL) is | — |
Countries
Italy
Outcome results
None listed