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CARTS研究:远端直肠癌的放化疗后行保留器官的经肛门内镜显微手术

The CARTS study: Chemoradiation therapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery.

作者信息

Bökkerink Guus M J, de Graaf Eelco J R, Punt Cornelis J A, Nagtegaal Iris D, Rütten Heidi, Nuyttens Joost J M E, van Meerten Esther, Doornebosch Pascal G, Tanis Pieter J, Derksen Eric J, Dwarkasing Roy S, Marijnen Corrie A M, Cats Annemieke, Tollenaar Rob A E M, de Hingh Ignace H J T, Rutten Harm J T, van der Schelling George P, Ten Tije Albert J, Leijtens Jeroen W A, Lammering Guido, Beets Geerard L, Aufenacker Theo J, Pronk Apollo, Manusama Eric R, Hoff Christiaan, Bremers Andreas J A, Verhoef Cornelelis, de Wilt Johannes H W

机构信息

Department of Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.

出版信息

BMC Surg. 2011 Dec 15;11:34. doi: 10.1186/1471-2482-11-34.

Abstract

BACKGROUND

The CARTS study is a multicenter feasibility study, investigating the role of rectum saving surgery for distal rectal cancer.

METHODS/DESIGN: Patients with a clinical T1-3 N0 M0 rectal adenocarcinoma below 10 cm from the anal verge will receive neoadjuvant chemoradiation therapy (25 fractions of 2 Gy with concurrent capecitabine). Transanal Endoscopic Microsurgery (TEM) will be performed 8 - 10 weeks after the end of the preoperative treatment depending on the clinical response.Primary objective is to determine the number of patients with a (near) complete pathological response after chemoradiation therapy and TEM. Secondary objectives are the local recurrence rate and quality of life after this combined therapeutic modality. A three-step analysis will be performed after 20, 33 and 55 patients to ensure the feasibility of this treatment protocol.

DISCUSSION

The CARTS-study is one of the first prospective multicentre trials to investigate the role of a rectum saving treatment modality using chemoradiation therapy and local excision. The CARTS study is registered at clinicaltrials.gov (NCT01273051).

摘要

背景

CARTS研究是一项多中心可行性研究,旨在探讨保留直肠手术在远端直肠癌治疗中的作用。

方法/设计:距肛缘10 cm以下的临床T1-3 N0 M0直肠腺癌患者将接受新辅助放化疗(25次,每次2 Gy,同时使用卡培他滨)。根据临床反应,在术前治疗结束后8 - 10周进行经肛门内镜显微手术(TEM)。主要目的是确定放化疗和TEM后(接近)完全病理缓解的患者数量。次要目的是这种联合治疗方式后的局部复发率和生活质量。在纳入20、33和55例患者后将进行三步分析,以确保该治疗方案的可行性。

讨论

CARTS研究是首批前瞻性多中心试验之一,旨在研究使用放化疗和局部切除的保留直肠治疗方式的作用。CARTS研究已在clinicaltrials.gov注册(NCT01273051)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e12/3295682/b12ab77e2a1d/1471-2482-11-34-1.jpg

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