Background
Phase III RCT (Swedish Rectal Cancer Trial). 1,168 patients with resectable rectal cancer randomized to preoperative short-course radiotherapy (25 Gy in 5 fractions, 1 week) followed by surgery within 1 week, versus surgery alone. TME was not yet standard. Long-term follow-up reported by Folkesson 2005.
Interventions and follow up
Arm A: Short-course RT 25 Gy in 5 fractions over 1 week → surgery within 1 week
Arm B: Surgery alone
Primary endpoint: Local recurrence, survival
mFollow up: 13 year
Arm B: Surgery alone
Primary endpoint: Local recurrence, survival
mFollow up: 13 year
Results
13-yr local recurrence: 9% vs 26%, P<.001
13-yr OS: 38% vs 30%, P=.008 — significant OS benefit
Cancer-specific survival: 72% vs 62%, P=.03
13-yr OS: 38% vs 30%, P=.008 — significant OS benefit
Cancer-specific survival: 72% vs 62%, P=.03
Adverse events
Main adverse events: Early reports showed higher postoperative complication rates with RT. Long-term late toxicity (bowel, sexual function) higher in RT arm. No RT-related cancer risk reported.
Conclusions
Preoperative short-course radiotherapy (25 Gy/5 fx) significantly reduced 13-year local recurrence (9% vs 26%) and improved OS (38% vs 30%) compared to surgery alone — the only rectal cancer RT trial to show an OS benefit. This established the efficacy of short-course preoperative RT in resectable rectal cancer.
Key Limitations
Key Limitations: Surgery was not TME — non-standardized technique likely inflated local recurrence rates in both arms. Results may not apply to modern TME surgery where local recurrence rates are much lower. Short-course RT (25 Gy) was not compared to long-course CRT. Short follow-up in the original trial; the 2005 13-year update substantially strengthened the OS data. Not designed for low rectal tumors or patients who could benefit from downstaging (where long-course CRT would be preferred).
Clinical Context
The Swedish trial established short-course preoperative RT (SCRT, 25 Gy/5 fx) as an effective treatment in resectable rectal cancer. The Stockholm III trial later compared SCRT to long-course CRT. SCRT has become widely accepted as a standard option for cT3N0-1 mid-upper rectal tumors not requiring downstaging. The Dutch trial and German Rectal Cancer Trial further refined indications using TME surgery.
References