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  • The CARTS study: Chemoradia...
    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

    BMC surgery, 12/2011, Letnik: 11, Številka: 1
    Journal Article

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