Background
Dutch TME trial. Phase III RCT enrolled 1,861 patients with treatment-naïve resectable rectal adenocarcinoma with the inferior margin <15 cm from the anal verge and below S1–S2, testing whether short-course preoperative radiotherapy adds benefit when TME is the standardized surgery.
Interventions and follow up
Arm A: Preoperative short-course RT 5 Gy x 5 days followed by TME
Arm B: TME alone
Primary endpoint: Local recurrence at 2 years
mFollow up: 2 yr
Arm B: TME alone
Primary endpoint: Local recurrence at 2 years
mFollow up: 2 yr
Results
2-yr local recurrence: 2.4% vs 8.2% (arm A vs B), P<.001; multivariate HR 3.41, 95%CI 2.05–5.70, P<.001
2-yr OS: 82.0% vs 81.8%, P=.84
2-yr OS: 82.0% vs 81.8%, P=.84
Adverse events
Surgical/wound: More perineal wound complications with preoperative RT
Late functional: Increased late bowel dysfunction and sexual dysfunction with RT plus TME vs TME alone
Late functional: Increased late bowel dysfunction and sexual dysfunction with RT plus TME vs TME alone
Conclusions
Short-course preoperative radiotherapy reduced 2-year local recurrence in resectable rectal cancer treated with standardized TME, without improving overall survival.
Key Limitations
Short initial follow-up (2 yr) for a chronic-relapse disease; no survival benefit; predates total neoadjuvant therapy and chemoradiation comparisons; positive circumferential margins still drove recurrence.
Clinical Context
Established short-course preoperative RT plus TME as a standard option for resectable rectal cancer in ESMO guidance. Long-term follow-up (van Gijn, Lancet Oncol 2011) confirmed durable local control benefit; later trials (RAPIDO, PRODIGE-23) added systemic therapy in the total neoadjuvant era.