Table 2.

Baseline assessment

• Review of inclusion and exclusion criteria

• Medical and medication history, physical examination including height, weight, vital signs (blood pressure, heart rate, respiratory rate, body temperature), oxygen saturation, ECOG-performance status

• Laboratory Tests:

o Hematology panel: hemoglobin, platelets, white blood cell (WBC) count and WBC differential (neutrophils, lymphocytes)

o Chemistry panel: sodium, potassium, calcium, magnesium, creatinine, urea, total bilirubin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein, albumin, LDH, glucose, amylase, lipase

o Free T3/T4 and TSH

o Coagulation: INR, aPTT

o CA 72–4 (CEA, CA 19–9 optional)

o Hepatitis B/C screening test (HBsAg, anti-HBc, anti-HBs, anti-HCV)

o HIV screening test (HIV 1/2 antigen/antibody test)

o Pregnancy test for women of childbearing potential within 24 h prior to start of the treatment

• Blood draw for translational research

• Obtain paraffin-embedded tumor-tissue for translational research

• Echocardiography and ECG

• Quality of life assessment (EORTC QLQ-C30 and STO-22)

• Disease assessment by radiological imaging of the chest, abdomen, pelvis and all other sites of disease (CT/MRI-scan)