Randomized Phase 3 Trial Comparing Preoperative and Postoperative Chemoradiotherapy With Capecitabine for Locally Advanced Rectal Cancer
Randomized Phase 3 Trial Comparing Preoperative and Postoperative Chemoradiotherapy With Capecitabine for Locally Advanced Rectal Cancer
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DOI：
10.1002/cncr.25943
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发表时间：
2011-08-15
期刊：
影响因子：
6.2
通讯作者：
Kim, Jin Cheon
中科院分区：
文献类型：
--
作者：
Park, Jin-hong;Yoon, Sang Min;Kim, Jin Cheon
背景：虽然许多试验显示术前放化疗（CRT）或术后放化疗（CRT）与单纯手术相比的疗效，但放化疗和手术的最佳顺序尚不清楚。作者报告了这项单机构前瞻性随机3期试验的最终结果，比较了术前CRT与术后CRT使用卡培他滨治疗局部晚期直肠癌的生存、局部控制、括约肌保存和毒性。方法：局部晚期直肠癌（cT3，潜在可切除的cT4或N+）患者随机分配接受术前或术后CRT。CRT包括50 Gy/25组，同时使用卡培他滨（1,650 mg/m(2)/天）。行全肠系膜切除。结果：2004年3月至2006年4月，共纳入240例患者。两臂的临床特征平衡良好，除了较低洼(
BACKGROUND: Although many trials have shown the efficacy of preoperative chemoradiotherapy (CRT) or postoperative CRT compared with surgery alone, the optimal sequence of radiotherapy and surgery is unclear. The authors reported the final results of this single institution prospective randomized phase 3 trial comparing preoperative CRT with postoperative CRT using capecitabine in survival, local control, sphincter preservation, and toxicity for the treatment of locally advanced rectal cancer. METHODS: Patients with locally advanced rectal cancer (cT3, potentially resectable cT4 or N+) were randomly assigned to receive preoperative or postoperative CRT. CRT consisted of 50 Gy/25 fractions and concurrent capecitabine (1,650 mg/m(2)/day). Total mesorectal excision was performed. RESULTS: From March 2004 to April 2006, 240 patients were enrolled. Clinical characteristics were well balanced between both arms, except for more low-lying (