metastatic colorectal cancer
Conditions
Brief summary
Objective response rate (ORR) according to RECIST 1.1 (assessment at the local trial center)
Detailed description
Overall survival (OS), Progression-free survival (PFS), Objective response rate (ORR) according to RECIST 1.1 (assessment by central review), Depth of response (DpR) (assessment by central review), Early tumor shrinkage ([ETS]; assessment by central review), QoL as assessed with the QoL questionnaire EQ-5D-5L, Type, incidence, severity, and causal relationship to IMPs of non-serious adverse events and serious adverse events (severity evaluated according to CTCAE version 5.0), Subsequent anti-tumor treatment lines (monotherapy and combination therapy treatment lines including medicinal products [chemotherapeutics, antibodies and targeted therapy] and investigator reported efficacy of subsequent treatment lines, Identification of biomarker for treatment efficacy and toxicity
Interventions
Sponsors
Charite Universitaetsmedizin Berlin KöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) according to RECIST 1.1 (assessment at the local trial center) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Progression-free survival (PFS), Objective response rate (ORR) according to RECIST 1.1 (assessment by central review), Depth of response (DpR) (assessment by central review), Early tumor shrinkage ([ETS]; assessment by central review), QoL as assessed with the QoL questionnaire EQ-5D-5L, Type, incidence, severity, and causal relationship to IMPs of non-serious adverse events and serious adverse events (severity evaluated according to CTCAE version 5.0), Subsequent anti-tumor treatment lines (monotherapy and combination therapy treatment lines including medicinal products [chemotherapeutics, antibodies and targeted therapy] and investigator reported efficacy of subsequent treatment lines, Identification of biomarker for treatment efficacy and toxicity | — |
Countries
Germany
Outcome results
None listed