previously untreated metastatic or locally advanced esophagogastric cancer
Conditions
Brief summary
Progression free survival 1 and neurotoxicity. Progression free survival 1 is defined as the time from start of study treatment, until the first moment of disease progression.
Detailed description
Progression free survival 2: in case of reintroduction of study treatment after progression, progression free survival 2 is the time until progression occurs after this reintroduction. In case of start of second line treatment after progression, the time from start until discontinuation of second line is taken as progression free survival 2., Quality of life, Overall survival, Response rate according to RECIST 1.1, Adverse events according to NCI CTCAE version 5.0., Percentage of patients proceeding to subsequent lines of treatment after progression and describe the types of subsequent treatments, Reasons for forgoing subsequent treatment after progression, To compare the primary and above mentioned secondary objectives for patients treated with and without nivolumab
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival 1 and neurotoxicity. Progression free survival 1 is defined as the time from start of study treatment, until the first moment of disease progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival 2: in case of reintroduction of study treatment after progression, progression free survival 2 is the time until progression occurs after this reintroduction. In case of start of second line treatment after progression, the time from start until discontinuation of second line is taken as progression free survival 2., Quality of life, Overall survival, Response rate according to RECIST 1.1, Adverse events according to NCI CTCAE version 5.0., Percentage of patients proceeding to subsequent lines of treatment after progression and describe the types of subsequent treatments, Reasons for forgoing subsequent treatment after progression, To compare the primary and above mentioned secondary objectives for patients treated with and without nivolumab | — |
Countries
Netherlands