Documentation | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | FU | FU | FU | FU | FU | FU | FU |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Screening | Before CTx | 4 weeks after CTx | Before surgery | Discharge | 3 months | 6 months | 9 months | 12 months | 18 months | 24 months | 30 months | |
Baseline data, demographics | X | |||||||||||
Eligibility criteria | X | |||||||||||
Endoscopy | X | X | ||||||||||
Clinical response | X | |||||||||||
Randomization | X | |||||||||||
Quality of life | X | X | X | |||||||||
Information about CTx | X | |||||||||||
R0 resection | X | |||||||||||
Histopathological response | X | |||||||||||
Information about surgery | X | |||||||||||
Perioperative morbidity | X | X | ||||||||||
Perioperative mortalitiy | X | X | ||||||||||
Severe adverse events | X | X | X | X | X | |||||||
Survival analysis/recurrence | X | X | X | X | X | X | X |