Pancreatic Cancer

The primary endpoint variable is the standardized area under the curve of the EORTC QLQ-C30 symptom summary score over the on-treatment period (visit 1-9).

Secondary endpoints will be evaluated by comparison of the two treatment groups.

• Standardized area under the curve of the EORTC QLQ-C30 symptom summary score over the maintenance period scores at visits 3-9
• Change of EORTC QLQ-C30 symptom summary score from baseline to visit 9
• Symptom scales of EORTC QLQ-C30 such as fatigue, pain, nausea and vomiting, dyspnoea, insomnia, appetite loss, constipation and diarrhea
• Global quality of life of the EORTC QLQ-C30
• Functional scales of the EORTC QLQ-C30 such as physical, role, cognitive, emotional and social
  Mean change from baseline of the Glasgow Prognostic Score and from baseline of serum levels of the score-defining biomarkers C-reactive protein (CRP) and albumin
• Amount of concomitant medication taken with special focus on antiemetic, psychotropic and pain medication
• Mean time to critical weight-loss (5%) after the 16 weeks treatment period assessed with a standard scale
• Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameters: Lean body mass (LBM = Fat free mass FFM), Total body water (TBW), Fat mass (FM), Body cell mass (BCM), Extracellular mass (ECM), Phase angle (PA), Resistance (Rz), Reactance (Xc)(1)
• Mean change from baseline of muscle strength measured by hand-grip strength test
  Proportion of patients not adhering to individual baseline chemotherapy regime (dose and time frame)
• Chemotherapeutic dose intensity over the treatment period of 18 weeks
• Frequency and severity of adverse events (AE) and serious adverse events (SAEs) assessed with Common Toxicity Criteria for Adverse Events (NCI-CTCAE V5.0)
• Incidence of adverse drug reactions (ARs)
• Progression-free survival (PFS) from treatment start until progression or death from any cause and overall survival (OS) from treatment start until death from any cause