Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is the treatment of choice although almost half of the resected patients get recurrence in the liver. The ASAC trial is a Scandinavian, multicentre, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose aspirin (acetylsalicylic acid (ASA)) can improve disease-free survival in patients treated for colorectal cancer liver metastases (CRCLM). Up to 800 patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2 Placebo, for a period of 3 years or until disease recurrence. The patients will be recruited at all major hepatobiliary surgical units in Norway, Sweden and Denmark and have follow-up according to standard of care and the National Guidelines. The ASAC trial will be the first clinical interventional trial to assess the potential beneficial role of ASA in recurrence of CRCLM and survival. ASA is an inexpensive, well-tolerated and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRCLM if the study shows a beneficial effect. We will also determine the effect of ASA as adjuvant treatment on Health-Related Quality of Life and the cost-effectiveness. ClinicalTrials.gov NCT03326791 . Registered on 31 October 2017.

中文翻译：

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阿司匹林作为结直肠癌肝转移二级预防（ASAC 试验）：多中心随机安慰剂对照试验的研究方案

结直肠癌是西方世界最常见的癌症之一，发病率不断增加。大约 50% 的患者会发生肝转移。肝转移瘤切除术是首选的治疗方法，尽管几乎一半的切除患者会在肝脏中复发。ASAC 试验是一项斯堪的纳维亚、多中心、双盲、随机、安慰剂对照研究，旨在确定低剂量阿司匹林（乙酰水杨酸 (ASA)）的辅助治疗是否可以改善接受结直肠癌肝转移治疗的患者的无病生存期(CRCLM)。多达 800 名接受 CRCLM 手术的患者将随机分配至第 1 组 ASA 160 毫克每日一次或第 2 组安慰剂组，为期 3 年或直至疾病复发。患者将在挪威所有主要肝胆外科单位招募，瑞典和丹麦并根据护理标准和国家指南进行随访。ASAC 试验将是第一个评估 ASA 在 CRCLM 复发和生存中的潜在有益作用的临床干预试验。ASA 是一种价格低廉、耐受性良好且易于获得的药物，如果该研究显示出有益效果，它将非常有可能作为 CRCLM 二级预防的辅助药物。我们还将确定 ASA 作为辅助治疗对健康相关生活质量和成本效益的影响。ClinicalTrials.gov NCT03326791。2017 年 10 月 31 日注册。如果研究显示出有益效果，那么这种耐受性良好且易于获得的药物将非常有可能作为 CRCLM 二级预防的辅助药物。我们还将确定 ASA 作为辅助治疗对健康相关生活质量和成本效益的影响。ClinicalTrials.gov NCT03326791。2017 年 10 月 31 日注册。如果研究显示出有益效果，那么这种耐受性良好且易于获得的药物将非常有可能作为 CRCLM 二级预防的辅助药物。我们还将确定 ASA 作为辅助治疗对健康相关生活质量和成本效益的影响。ClinicalTrials.gov NCT03326791。2017 年 10 月 31 日注册。