COLOR II. 一项比较腹腔镜手术与开放手术治疗直肠癌的随机临床试验。
COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer.
作者信息
Buunen M, Bonjer H J, Hop W C J, Haglind E, Kurlberg G, Rosenberg J, Lacy A M, Cuesta M A, D'Hoore A, Fürst A, Lange J F, Jess P, Bulut O, Poornoroozy P, Jensen K Juul, Christensen M Mark, Lundhus E, Ovesen H, Birch D, Iesalnieks I, Jäger C, Kreis M, van riet Y, van der Harst E, Gerhards M F, Bemelman W A, Hansson B M E, Neijenhuis P A, Prins H A, Balague C, Targarona E, Luján Mompeán J A, Franco Osorio J D, Garcia Molina F J, Skullman S, Läckberg Z, Kressner U, Matthiessen P, Kim S H, Poza A Alfredo
出版信息
Dan Med Bull. 2009 May;56(2):89-91.
INTRODUCTION
Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial.
TRIAL DESIGN
Non-inferiority randomized clinical trial.
METHODS
The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis.
RESULTS
By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%).
CONCLUSION
Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009.
TRIAL REGISTRATION
Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).
引言
腹腔镜直肠癌切除术已被证明是有效的，但发病率和肿瘤学结果需要在一项随机临床试验中进行研究。
试验设计
非劣效性随机临床试验。
方法
COLOR II试验是一项正在进行的国际随机临床试验。目前，来自欧洲、韩国和加拿大的27家医院正在纳入患者。主要终点是术后三年的局部区域复发率。次要终点包括生活质量、总生存率和无病生存率、术后发病率以及卫生经济学分析。
结果
截至2008年7月，来自荷兰、比利时、德国、瑞典、西班牙、丹麦、韩国和加拿大的27家医院已纳入739例患者。腹腔镜组的术中中转率为17%。两个治疗组在年龄、肿瘤位置和放疗方面的分布相同。大多数肿瘤位于直肠中部（41%）。
结论
腹腔镜手术治疗直肠癌是可行的。腹腔镜手术治疗直肠癌的结果和安全性尚不清楚，但将在COLOR II试验中进行中期分析。预计2009年底完成入组。
试验注册
Clinicaltrials.gov，标识符：NCT00297791（www.clinicaltrials.gov）。
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