METHODS: This is a multicenter, prospective, non-inferior, randomized controlled trial (RCT) initiated by West China Hospital of Sichuan University and designed to be conducted in fourteen hospitals around China. Eligible patients will be centrally randomized into 2 or 4 cycles of CAPOX in a 1:1 ratio using the central automated randomization system offered by the O-trial online system ( https://plus.o-trial.com/ ) and accept total mesorectal excision after 2 or 4 cycles of CAPOX (oxaliplatin 130 mg/m2, once daily on day 1, every 21 days and capecitabine 1000 mg/m2, twice daily on days 1 to 14, every 21 days). The primary endpoint is the proportion of patients with pathological no-tumor regression (pTRG 3), which is determined postoperatively by each sub-center and verified by the primary center.
CONCLUSIONS: COPEC trial is designed to verify that the preoperative CAPOX chemotherapy for low- and intermediate-risk stage II/III rectal cancer could achieve a good response judgment after 2 cycles and obtain the tumor pathological response rate after 2 cycles of CAPOX. We hope the COPEC trial could help in establishing a consensus standard of low- and intermediate-risk rectal cancer and the early identification of stage II/III rectal patients with low- and intermediate-risk who are poorly responding to NCT.
BACKGROUND: Clinicaltrial.gov NCT04922853. Registered on June 4, 2021.
方法:这是一个多中心,prospective,非劣质,随机对照试验(RCT)由四川大学华西医院发起,旨在在中国14家医院进行。符合条件的患者将使用O-trial在线系统(https://plus)提供的中央自动随机系统以1:1的比例集中随机分为2或4个CAPOX周期。o-trial.com/),并在接受CAPOX2或4个周期后接受全直肠系膜切除术(奥沙利铂130mg/m2,第1天每天一次,每21天,卡培他滨1000mg/m2,第1天每天两次至14天,每21天)。主要终点是病理性无肿瘤消退(pTRG3)患者的比例,术后由每个子中心确定,并由主中心验证。
结论:COPEC试验旨在验证术前CAPOX化疗方案对低、中危II/III期直肠癌患者在2个周期后能取得良好的反应判断,并获得2个周期后的肿瘤病理反应率。我们希望COPEC试验可以帮助建立低和中危直肠癌的共识标准,并早期识别对NCT反应不佳的低和中危II/III期直肠患者。
背景:Clinicaltrial.govNCT04922853。2021年6月4日注册。