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Abstract：
BACKGROUND: For patients with low- and intermediate-risk stage II/III rectal cancer, current studies have reached a consensus that preoperative radiotherapy may be dispensed with, and neoadjuvant chemotherapy (NCT) alone might achieve an accepted local control. Our previous phase II study has evidenced that the morphological response of NCT could be better judged at a relatively early stage. Low- and intermediate-risk stage II/III rectal cancer patients could achieve a high rate of tumor shrinkage and downgrade after only 4 cycles of NCT and obvious tumor morphological changes could be observed after 2 cycles of NCT. However, there is still a lack of more detailed stratification and evidence for pathological criteria. The aim of the present study (comparison of the pathological response to 2 or 4 cycles of neoadjuvant CAPOX in II/III rectal cancer patients with low/intermediate risks, COPEC trial) is to determine the pathological tumor regression grade (pTRG) rate of 2 or 4 cycles of NCT in low- and intermediate-risk stage II/III rectal cancer and verify the feasibility of early identification of chemotherapy-insensitive population.
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.
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.
摘要：
背景：对于低危和中危II/III期直肠癌患者，目前的研究已经达成共识，可以免除术前放疗，和新辅助化疗（NCT）单独可能达到公认的局部控制。我们先前的II期研究证明，可以在相对较早的阶段更好地判断NCT的形态反应。低危和中危II/III期直肠癌患者仅需4个周期的NCT即可达到较高的肿瘤缩小和降级率，2个周期的NCT后可观察到明显的肿瘤形态学改变。然而,目前仍缺乏更详细的分层和病理标准证据.本研究的目的（比较低/中等风险的II/III期直肠癌患者对新辅助CAPOX的2或4个周期的病理反应，COPEC试验）是确定低危和中危II/III期直肠癌中2或4个周期NCT的病理肿瘤消退等级（pTRG）率，并验证早期识别化疗不敏感人群的可行性。
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。
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。
