第51屆美國臨床腫瘤學(xué)會（ASCO）年會即將在期待中拉開序幕。中山大學(xué)腫瘤醫(yī)院的陳功教授團隊正在進行的一項研究將在壁報中展示。該研究是探索無癥狀的、轉(zhuǎn)移灶不可切除的結(jié)直腸癌患者手術(shù)切除原發(fā)灶的有效性的首個多中心、隨機對照、開放標簽的III期研究（摘要號#117a）。對此進行了報道。

    對于無癥狀性結(jié)直腸癌伴有不可切除轉(zhuǎn)移病灶的患者對原發(fā)腫瘤進行姑息切除是否能得到益處尚不明確?；仡櫺匝芯匡@示的結(jié)果具有爭議性：一些接受原發(fā)腫瘤切除的患者能夠?qū)⑺麄兊目偵鏁r期提高6個月的時間。因此，研究人員計劃啟動用以評估無癥狀性、轉(zhuǎn)移性、對初始化療敏感的結(jié)直腸癌患者接受原發(fā)性腫瘤切除的有效性的首個隨機研究。

    相關(guān)報道：轉(zhuǎn)移瘤不可切除的晚期結(jié)直腸癌原發(fā)瘤切除的共識與爭議該研究的首要觀察終點為基于***評估的總體生存期。次要觀察終點包括無進展生存期（PFS）、健康相關(guān)的生活質(zhì)量（HRQoL）和毒副作用。該研究設(shè)計具有80%效用可以檢測手術(shù)組總生存期0.71的風(fēng)險比（從15個月到21個月）。來自處于0.02單側(cè)時序檢驗在0.025顯著水平的結(jié)果將會呈現(xiàn)出來。

    基于這些假設(shè)，一共需要觀察480名患者的320件事件。對于所有無癥狀性結(jié)直腸癌伴有不可切除的轉(zhuǎn)移性病灶且同意加入研究的患者將接受6個月的篩選化療（任何有用的一線化療都可以使用，除貝伐單抗外，因其可影響手術(shù)的安全性）。那些對化療反應(yīng)或穩(wěn)定的患者將按1:1比例隨機分為接受手術(shù)切除原發(fā)腫瘤組和繼續(xù)化療組。接受手術(shù)組的患者在手術(shù)恢復(fù)后將接受化療。開始招募的時間為2015年3月。試驗的持續(xù)時間為72個月（36個月招募和36個月隨訪）。臨床信息：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