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

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

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).

Figures

Figure 1
Figure 1
flowchart of the CARTS-study.

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