Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan.
Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Tokyo, Japan.
Jpn J Clin Oncol. 2020 Jan 24;50(1):89-93. doi: 10.1093/jjco/hyz173.
It is controversial whether chemotherapy with or without primary tumour resection is effective for the patients with incurable Stage IV colorectal cancer. A randomized controlled trial, initiated in Japan in 2012, is being conducted to evaluate the survival benefit and safety of primary tumour resection plus chemotherapy compared with chemotherapy alone in asymptomatic Stage IV colorectal cancer patients with unresectable metastatic disease. Patients are randomly assigned to either chemotherapy alone or primary tumour resection followed by chemotherapy. The primary endpoint is overall survival. Secondary endpoints are progression-free survival, incidence of adverse events, proportion of patients with R0 resection and proportion of palliative surgery for the chemotherapy-alone group. This trial was registered in June 2012 with the UMIN Clinical Trials Registry as UMIN000008147 [http://www.umin.ac.jp/ctr/index-j.htm]. In December 2017, the study protocol was amended for reducing sample size. A total of 280 patients will be enrolled over the course of 8.5 years.
对于不可治愈的 IV 期结直肠癌患者,化疗联合或不联合原发肿瘤切除术是否有效尚存争议。一项于 2012 年在日本启动的随机对照试验正在进行中,旨在评估与单独化疗相比,原发肿瘤切除术联合化疗对无症状 IV 期结直肠癌患者不可切除的转移性疾病的生存获益和安全性。患者被随机分配至单独化疗或原发肿瘤切除后化疗组。主要终点为总生存期。次要终点为无进展生存期、不良事件发生率、R0 切除率和化疗组姑息性手术比例。该试验于 2012 年 6 月在 UMIN 临床试验注册中心注册,注册号为 UMIN000008147[http://www.umin.ac.jp/ctr/index-j.htm]。2017 年 12 月,该研究方案进行了修订以减少样本量。预计在 8.5 年内共招募 280 名患者。