advanced, non resectable or metastatic cholangio- or gallbladder carcinoma after failure to respond to a previous gemcitabine treatment
Conditions
Brief summary
Median progression free survival (PFS) assessed by the local investigator at each site (time from first administration of chemotherapy to the date of radiological or clinical tumor progression or death of any cause whichever comes first).
Detailed description
Progression-free survival rate at 4 months defined as the proportion of patients with non-progressive disease 4 months after inclusion by intention to treat analysis, Median overall survival (time interval from first administration of chemotherapy to date of death from any cause), Proportion of patients with an objective response according to RECIST 1.1, Type, frequency and severity of adverse events according to NCI CTCAE version 5.0 specifying seriousness and expectedness (AE, SAE, SUSAR), Health related QoL according to EORTC QLQ C30 and the EQ-5D-5L
Interventions
Sponsors
Heinrich-Heine-Universitaet Duesseldorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression free survival (PFS) assessed by the local investigator at each site (time from first administration of chemotherapy to the date of radiological or clinical tumor progression or death of any cause whichever comes first). | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at 4 months defined as the proportion of patients with non-progressive disease 4 months after inclusion by intention to treat analysis, Median overall survival (time interval from first administration of chemotherapy to date of death from any cause), Proportion of patients with an objective response according to RECIST 1.1, Type, frequency and severity of adverse events according to NCI CTCAE version 5.0 specifying seriousness and expectedness (AE, SAE, SUSAR), Health related QoL according to EORTC QLQ C30 and the EQ-5D-5L | — |
Countries
Germany
Outcome results
None listed