Table 1.
Required measures | Screening/ trial entry | Visceral debranching as soon as possible after trial entry | During neoadjuvant chemotherapy intended start date 2 to 3 weeks after debranching | Tumor resection intended date of operation 4–6 weeks after end of chemotherapy | Follow-up 0–36 months after tumor resection |
---|---|---|---|---|---|
Verification of inclusion and exclusion criteria | ♦ | ||||
Informed consent | ♦ | ||||
CT/MRI | ♦ | ♦ Between end of chemotherapy and resection |
♦ | ||
Ascertainment of data as detailed in “evaluation and follow-up” | ♦ | ♦ | ♦ | ♦ | |
Ascertainment of primary endpoint | ♦ Start of neoadjuvant chemotherapy |
||||
Follow-up exams at the discretion of the treating physician (including Ca 19-9 measurements and cross-sectional imaging as indicated) | ♦ | ||||
Surgery | ♦ | ♦ |
Measures to be performed at the time points marked with ♦