Procedures | Screening and inclusion | Baseline6 | MR-guided adaptive SBRT (Arm A only) | Week 4 post randomization | Every 4 weeks post randomization1 | Every 3 months post randomization | Study termination (18 months post randomization) |
---|---|---|---|---|---|---|---|
Informed consent, demographic data, in-/exclusion criteria, medical history | √ | ||||||
Physical examination9 | √ | √2 | √ | √ | √ | ||
Laboratory assessment8 | √ | √ | √ | √ | |||
Study specific blood and urine collection7 | √ | √ | √3 | ||||
Pain assessment10 | √ | √ | √4 | √5 | |||
Assessment of biliary complications11 | √ | √ | √ | √ | |||
Assessment of nutritional status12 | √ | √ | √ | √ | |||
Assessment of quality of life13 | √ | √ | √ | √ | |||
Randomization | √ | √ | √ | ||||
Review of imaging | √ | √ | √ | ||||
MR-guided adaptive SBRT | √ | ||||||
Concomitant disease | √ | √ | √ | √ | |||
Concomitant medication | √ | √ | √ | √ | √ | √ | |
Adverse events and toxicity | √ | √ | √ | √ |