Advanced neuroendocrine neoplasias G3 (NEN G3) (excluding SCLC and Merkel cell carcinomas)
Conditions
Brief summary
Disease control rate (DCR: CR, PR, SD) according to iRECIST after 16 weeks from start of treatment until documented disease progression (PD)
Detailed description
Disease control rate (DCR) at week 8, week 24, week 48, Objective response rate (ORR), Best overall response (BOR), Duration of disease control (DDC), Time to response (TTR), Progression-free survival time (PFS), Evaluation of tumor response according to RECIST 1.1, Overall survival (OS), Quality of life (QoL) assessed by EORTC QLQ-C30, Number, severity, and duration of treatment-emergent AEs according to NCI-CTCAE v5.0, Dose reduction of study drugs, Treatment interruption or termination of study drugs due to adverse events
Interventions
Sponsors
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR: CR, PR, SD) according to iRECIST after 16 weeks from start of treatment until documented disease progression (PD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) at week 8, week 24, week 48, Objective response rate (ORR), Best overall response (BOR), Duration of disease control (DDC), Time to response (TTR), Progression-free survival time (PFS), Evaluation of tumor response according to RECIST 1.1, Overall survival (OS), Quality of life (QoL) assessed by EORTC QLQ-C30, Number, severity, and duration of treatment-emergent AEs according to NCI-CTCAE v5.0, Dose reduction of study drugs, Treatment interruption or termination of study drugs due to adverse events | — |
Countries
Germany
Outcome results
None listed