Table 1

Time and events table

Required measuresScreening (≤14 days before study entry)d7d14d22–28≥d29Three-monthly until end of follow-up (36 months/recurrence/death)
Informed consent
History, ECOG PS, toxicity/compliance assessment
Physical assessment including pulse, blood pressure, weight, cancer symptoms♦*
Complete blood count, sodium, potassium, creatinine, bilirubin, alkaline phosphatase, AST, ALT, glucose, albumin, PT/INR, PTT, fT4, TSH♦†
UPC
12-lead ECG
Pregnancy test
Chest CT
MRI of tumour region (on screening and on d22–28 according to specific protocol; during follow-up according to local clinical practice)♦‡♦‡
FDG-dPET-CT of tumour region
Surgery (not part of study protocol)
cEPC/sVEGF levels♦(14 days after surgery)
  • *Monitoring of BP: a measurement of BP should be taken at 7±3 days. BP can be assessed by any method (ie, at home or by another physician) as long as the study physician is informed of the measurement, verifies any measurement that is not normal and takes appropriate action.

  • †Only LFTs.

  • ‡Optional according to local availability.

  • ALT, alanine aminotransferase; AST, aspartate aminotransferase; BP, blood pressure; cEPC, circulating endothelial progenitor cell; ECOG PS, Eastern Cooperative Oncology Group performance status; FDG, fluorodeoxyglucose; INR, international normalisation ratio; LFT, liver function test; PET, positron emission tomography; PT, prothrombin time; PTT, partial thromboplastin time; sVEGF, soluble vascular epithelial growth factor; TSH, thyroid-stimulating hormone; UPC, urine protein creatinine ratio.