Yeh Yung-Sung, Tsai Hsiang-Lin, Huang Ching-Wen, Wei Po-Li, Sung Yung-Chuan, Tang Hsiu-Chih, Wang Jaw-Yuan
Division of Trauma and Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Trials. 2017 Apr 26;18(1):191. doi: 10.1186/s13063-017-1904-9.
We conducted a prospective randomized study of an adjuvant oxaliplatin-based regimen plus orally administered tegafur-uracil in patients with stage III colon cancer after radical resection to evaluate the feasibility of this drug combination in cancer clinical outcomes, acute toxicity, disease-free survival (DFS), and overall survival (OS) in Taiwan.
METHODS/DESIGN: This is an open-label, randomized, comparative, double-arm, multicenter, phase III study to assess DFS, OS, and safety profiles of the aforementioned drug combination as maintenance therapy for 1 year in patients with stage III colon cancer after radical resection in Taiwan. Following the completion of an adjuvant oxaliplatin-based regimen for 3 weeks with no evident disease recurrence, all eligible patients will be randomly assigned to either arm A (maintenance therapy) or arm B (observation arm) in a 2:1 ratio (364 and 182 patients in the tegafur-uracil and observation groups, respectively). Treatment in arm A will be started within 7 days of randomization. If the patients reported disease recurrence, intolerable toxicity, withdrew consent or the investigator determined that the patient should be withdrawn during the study period, they were withdrawn from the study. If a patient was discontinued from the study, the corresponding data were not reused, and the patient was not allowed to re-enter the study.
A unique characteristic of this intervention was that the adjuvant chemotherapy with oxaliplatin and tegafur-uracil was anticipated to be safe and has high treatment efficacy, with the advantage of yielding a favorable response rate and tolerable toxicity profile.
ClinicalTrials.gov, identifier: NCT02836977 . Registered on 18 July 2016.
我们对根治性切除术后的III期结肠癌患者进行了一项前瞻性随机研究，采用基于奥沙利铂的辅助方案加口服替加氟-尿嘧啶，以评估该药物组合在台湾癌症临床结局、急性毒性、无病生存期（DFS）和总生存期（OS）方面的可行性。
方法/设计：这是一项开放标签、随机、对照、双臂、多中心III期研究，旨在评估上述药物组合作为台湾根治性切除术后III期结肠癌患者1年维持治疗的DFS、OS和安全性。在完成3周基于奥沙利铂的辅助方案且无明显疾病复发后，所有符合条件的患者将按2:1的比例随机分配至A组（维持治疗）或B组（观察组）（替加氟-尿嘧啶组和观察组分别为364例和182例患者）。A组治疗将在随机分组后7天内开始。如果患者报告疾病复发、出现无法耐受的毒性、撤回同意或研究者在研究期间确定患者应退出研究，则将其从研究中撤回。如果患者退出研究，相应数据将不再使用，且患者不允许重新进入研究。
该干预措施的一个独特之处在于，奥沙利铂和替加氟-尿嘧啶的辅助化疗预计是安全的，且具有较高的治疗效果，具有产生良好缓解率和可耐受毒性特征的优势。
ClinicalTrials.gov，标识符：NCT02836977。于2016年7月18日注册。
