1. Objectives | |
1.1. Primary Objectives | |
• To assess the efficacy of neoadjuvant multimodal chemotherapy followed by R0/R1 resection in patients with hepatic oligometastatic adenocarcinoma of the pancreas | |
1.2. Secondary Objectives | |
• To determine efficacy and safety of the treatment concept | |
• To determine health-related quality of life (HR-QoL) | |
1.3. Other Exploratory Objectives | |
• To analyze HR-QoL-adjusted overall survival | |
2. Endpoints | |
2.1. Primary Endpoint | |
• Overall survival after R0/R1 resection (OS-res) (only patients with R0/R1 resection) | |
2.2. Secondary Endpoints | |
Efficacy | |
• R0/R1 resection rate after neoadjuvant chemotherapy | |
• Overall survival | |
• Progression-free survival (PFS) after R0/R1 resection according to RECIST v1.1 | |
Safety | |
• Type, frequency and severity of adverse events with severity according to NCI CTCAE version 5.0 (neoadjuvant chemotherapy) | |
• Perioperative morbidity and mortality | |
Health-Related Quality of Life | |
• HR-QoL according to EORTC QLQ-C30 and EORTC QLQ-PAN26 questionnaires | |
2.3. Other, Exploratory Endpoints | |
• HR-QoL-adjusted OS |