locally advanced rectal cancer
Conditions
Brief summary
The primary endpoint of this trial is disease-free survival, defined as the 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.
Detailed description
Acute and late toxicity assessment according to NCI CTCAE version 5.0, Compliance (completion rate) of chemotherapy, Surgical morbidity and complications, Pathological UICC-staging, including pCR (ypT0N0) rate, R0 resection rate; negative circumferential resection rate (CRM > 1mm), Tumor regression grading according to Dworak in the experimental arm, Rate of sphincter-sparing surgery, Rate of W&W with or without local regrowth, Cumulative incidence of local and distant recurrences, Overall survival, Quality of life and functional outcome based on treatment arm, and surgical procedures
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this trial is disease-free survival, defined as the 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute and late toxicity assessment according to NCI CTCAE version 5.0, Compliance (completion rate) of chemotherapy, Surgical morbidity and complications, Pathological UICC-staging, including pCR (ypT0N0) rate, R0 resection rate; negative circumferential resection rate (CRM > 1mm), Tumor regression grading according to Dworak in the experimental arm, Rate of sphincter-sparing surgery, Rate of W&W with or without local regrowth, Cumulative incidence of local and distant recurrences, Overall survival, Quality of life and functional outcome based on treatment arm, and surgical procedures | — |
Countries
Germany