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

    對于無(wú)癥狀性結直腸癌伴有不可切除轉移病灶的患者對原發(fā)腫瘤進(jìn)行姑息切除是否能得到益處尚不明確。回顧性研究顯示的結果具有爭議性：一些接受原發(fā)腫瘤切除的患者能夠將他們的總生存時(shí)期提高6個(gè)月的時(shí)間。因此，研究人員計劃啟動(dòng)用以評估無(wú)癥狀性、轉移性、對初始化療敏感的結直腸癌患者接受原發(fā)性腫瘤切除的有效性的首個(gè)隨機研究。

    相關(guān)報道：轉移瘤不可切除的晚期結直腸癌原發(fā)瘤切除的共識與爭議該研究的首要觀(guān)察終點(diǎn)為基于***評估的總體生存期。次要觀(guān)察終點(diǎn)包括無(wú)進(jìn)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(gè)月到21個(gè)月）。來(lái)自處于0.02單側時(shí)序檢驗在0.025顯著(zhù)水平的結果將會(huì )呈現出來(lái)。

    基于這些假設，一共需要觀(guān)察480名患者的320件事件。對于所有無(wú)癥狀性結直腸癌伴有不可切除的轉移性病灶且同意加入研究的患者將接受6個(gè)月的篩選化療（任何有用的一線(xiàn)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）。那些對化療反應或穩定的患者將按1:1比例隨機分為接受手術(shù)切除原發(fā)腫瘤組和繼續化療組。接受手術(shù)組的患者在手術(shù)恢復后將接受化療。開(kāi)始招募的時(shí)間為2015年3月。試驗的持續時(shí)間為72個(gè)月（36個(gè)月招募和36個(gè)月隨訪(fǎng)）。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