第51届美国临床肿瘤学会（ASCO）年会即将在期待中拉开序幕。中山大学肿瘤医院的陈功教授团队正在进行的一项研究将在壁报中展示。该研究是探索无症状的、转移灶不可切除的结直肠癌患者手术切除原发灶的有效性的首个多中心、随机对照、开放标签的III期研究（摘要号#117a）。对此进行了报道。

    对于无症状性结直肠癌伴有不可切除转移病灶的患者对原发肿瘤进行姑息切除是否能得到益处尚不明确。回顾性研究显示的结果具有争议性：一些接受原发肿瘤切除的患者能够将他们的总生存时期提高6个月的时间。因此，研究人员计划启动用以评估无症状性、转移性、对初始化疗敏感的结直肠癌患者接受原发性肿瘤切除的有效性的首个随机研究。

    相关报道：转移瘤不可切除的晚期结直肠癌原发瘤切除的共识与争议该研究的首要观察终点为基于***评估的总体生存期。次要观察终点包括无进展生存期（PFS）、健康相关的生活质量（HRQoL）和毒副作用。该研究设计具有80%效用可以检测手术组总生存期0.71的风险比（从15个月到21个月）。来自处于0.02单侧时序检验在0.025显著水平的结果将会呈现出来。

    基于这些假设，一共需要观察480名患者的320件事件。对于所有无症状性结直肠癌伴有不可切除的转移性病灶且同意加入研究的患者将接受6个月的筛选化疗（任何有用的一线化疗都可以使用，除贝伐单抗外，因其可影响手术的安全性）。那些对化疗反应或稳定的患者将按1:1比例随机分为接受手术切除原发肿瘤组和继续化疗组。接受手术组的患者在手术恢复后将接受化疗。开始招募的时间为2015年3月。试验的持续时间为72个月（36个月招募和36个月随访）。临床信息：NCT02149784

    摘要原文

    Background: It is still unclear whether asymptomatic colorectal cancer patients with unresectable metastatic disease can benefit from palliative resection of primary tumor. Retrospective studies showed a controversial result that some patients who received the resection of the primary tumor would prolong their overall survival time for 6 months. We plan to initiate the first randomized study to evaluate the efficacy of the resection of primary tumor in asymptomatic metastatic colorectal cancer patients who respond to initial chemotherapy.

    Methods: This is a multi-center, randomized, controlled, open label, phase III study. The primary endpoint of the study was overall survival （OS） based on independent assessment. Secondary end-points include progress free survival （PFS）， health-related quality of life （HRQoL） and toxicity profiles. The study was designed to have 80% power to detect a 0.71 HR of OS in surgery arm （from 15 month to 21 month）。

    Results from a one-sided log rank test at 0.025 significance level will be presented. Based on these assumptions, a total of 480 patients are needed to observe 320 events. All asymptomatic colorectal cancer patients with unresectable metastatic disease who agree to join this study will receive screening chemotherapy （any useful first line chemotherapy can be used here, except -becacizumab-which may affect the safety of surgery） for 6 months. Those who respond to chemotherapy or stable will be randomly assigned （1:1） to receive surgical resection of the primary tumor or continue chemotherapy. The patients in surgery group will receive chemotherapy after recover from surgery. Recruitment will begin in March 2015. The duration of the trial will be 72 months （36 months recruitment and 36 months follow-up）。 Clinical trial ***rmation: NCT02149784