Dutch tme trial nejm

Safety was assessed by intention to treat. Findings: Between June 21, , and June 2, , patients were enrolled and randomly assigned to a treatment, of whom were eligible in the experimental group; in the standard of care group.

Treatment-related deaths occurred in four participants in the experimental group one cardiac arrest, one pulmonary embolism, two infectious complications and in four participants in the standard of care group one pulmonary embolism, one neutropenic sepsis, one aspiration, one suicide due to severe depression. Interpretation: The observed decreased probability of disease-related treatment failure in the experimental group is probably indicative of the increased efficacy of preoperative chemotherapy as opposed to adjuvant chemotherapy in this setting.

Therefore, the experimental treatment can be considered as a new standard of care in high-risk locally advanced rectal cancer.

Abstract Background: Systemic relapses remain a major problem in locally advanced rectal cancer. Associated data ClinicalTrials. Randomisation was based on permuted blocks of six with stratification according to centre and expected type of surgery. The primary endpoint was local recurrence, analysed for all eligible patients who underwent a macroscopically complete local resection.

The effect of radiotherapy became stronger as the distance from the anal verge increased. However, when patients with a positive circumferential resection margin were excluded, the relation between distance from the anal verge and the effect of radiotherapy disappeared.

Patients assigned to radiotherapy had a lower overall recurrence and when operated with a negative circumferential resection margin, cancer-specific survival was higher.