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

G.M. Bokkerink, E. J. de Graaf, C.J. Punt, I.D. Nagtegaal, H.J.T. Rutten, J.J. Nuyttens, E. van Meerten, P.G. Doornebosch, P.J. Tanis, E.J. Derksen, R.S. Dwarkasing, C.A. Marijnen, A. Cats, R.A. Tollenaar, I.H. de Hingh, H.J. Rutten, G.P. van der Schelling, A.J. Ten Tije, J.W. Leijtens, G. LammeringG.L. Beets, T.J. Aufenacker, A. Pronk, E.R. Manusama, C. Hoff, A.J. Bremers, C. Verhoef, J.H. de Wilt

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

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).
Original languageEnglish
Pages (from-to)34
JournalBMC Surgery
Volume11
Issue number1
DOIs
Publication statusPublished - 1 Jan 2011

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