Loading...
time from randomisation to one of the following events: no surgery or non-radical (R2) surgery of the primary tumour, locoregional recurrence after R0/1 resection of the primary tumour, second primary colorectal or other cancer, metastatic disease or progression, or death from any cause, whichever occurred first.
assessment of acute and late toxicity according to NCI CTCAE version 5.0
Rate of completion of administered chemotherapy
Surgical morbidity and complications if surgery is performed and events occur
Pathological staging according UICC criteria, including detailed information about pathologically assessed complete response rate (ypT0N0)
defined as microscopically margin negative resection with no gross or microscopic tumor remains in the area of the primary tumor and/or samples regional lymph nodes based on evaluation by the local pathologist
Grading of tumor regression according to Dworak in the experimental arm
Rate of sphincter-sparing surgery if surgery is performed
Number of performed watch&wait approaches with or without local regrowth compared to planned and performed surgery
Total number of local and distant recurrences, if they occur
Overall survival is defined as the time interval between the date of randomization and the date of death of any cause. Patients who are still alive when last traced will be censored at the date of last follow-up
Quality of life scores according to validated questionnaires EORTC-QLQ-C30, based on treatment arm, and surgical procedures. 30 questions; score values from 1 (not at all) to 4 (very much) respectively from 1 (very poor) to 7 (excellent). Score outcome depends on score type.
Quality of life scores according to validated questionnaires EORTC-QLQ-CR29, based on treatment arm, and surgical procedures. 29 questions; score values from 1 (not at all) to 4 (very much). Score outcome depends on score type.
Functional score according to validated Wexner score, based on treatment arm, and surgical procedures. 5 questions; five score values from "never" to "1 per day or more often". The more often the worse the outcome.