Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden.
Br J Surg. 2010 Apr;97(4):580-7. doi: 10.1002/bjs.6914.
To address issues regarding the fractionation of radiotherapy (RT) and timing of surgery for rectal cancer, a multicentre trial has randomized patients to preoperative short-course RT with two different intervals to surgery, or long-course RT with delayed surgery. The present interim analysis assessed feasibility, compliance and complications after RT and surgery.
Some 303 patients were randomized to either short-course RT (5 x 5 Gy) and surgery within 1 week (group 1), short-course RT and surgery after 4-8 weeks (group 2) or long-course RT (25 x 2 Gy) and surgery after 4-8 weeks (group 3).
Demographic data were similar between groups and there were few protocol violations (5.0-6 per cent). Eight patients (2.6 per cent) developed radiation-induced acute toxicity. There were no significant differences in postoperative complications between groups (46.6, 40.0 and 32 per cent in groups 1, 2 and 3 respectively; P = 0.164). Patients receiving short-course RT with surgery 11-17 days after the start of RT had the highest complication rate (24 of 37).
Compliance was acceptable and severe acute toxicity was low, irrespective of fractionation. Short-course RT with immediate surgery had a tendency towards more postoperative complications, but only if surgery was delayed beyond 10 days after the start of RT.
NCT00904813 (http://www.clinicaltrials.gov).
为了解决直肠癌放疗分割和手术时机的问题，一项多中心试验将患者随机分为术前短程放疗，两种不同间隔时间进行手术，或长程放疗，延迟手术。本中期分析评估了放疗和手术后的可行性、依从性和并发症。
303 例患者被随机分为短程放疗（5 x 5 Gy），术后 1 周内手术（组 1），短程放疗，术后 4-8 周手术（组 2）或长程放疗（25 x 2 Gy），术后 4-8 周手术（组 3）。
各组间的人口统计学数据相似，且方案违规较少（5.0-6%）。8 例（2.6%）发生放射性急性毒性。各组之间的术后并发症无显著差异（组 1、2 和 3 的分别为 46.6%、40.0%和 32.0%；P = 0.164）。接受短程放疗，放疗开始后 11-17 天手术的患者并发症发生率最高（37 例中有 24 例）。
无论分割如何，依从性可接受，严重急性毒性较低。短程放疗后立即手术有增加术后并发症的趋势，但只有在放疗开始后 10 天以上延迟手术时才会出现。
NCT00904813（http://www.clinicaltrials.gov）。
