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Open Access Highly Accessed Study protocol

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

Guus MJ Bökkerink1*, Eelco JR de Graaf2, Cornelis JA Punt3, Iris D Nagtegaal4, Heidi Rütten5, Joost JME Nuyttens6, Esther van Meerten7, Pascal G Doornebosch2, Pieter J Tanis8, Eric J Derksen9, Roy S Dwarkasing10, Corrie AM Marijnen11, Annemieke Cats12, Rob AEM Tollenaar13, Ignace HJT de Hingh14, Harm JT Rutten14, George P van der Schelling15, Albert J ten Tije16, Jeroen WA Leijtens17, Guido Lammering18, Geerard L Beets19, Theo J Aufenacker20, Apollo Pronk21, Eric R Manusama22, Christiaan Hoff22, Andreas JA Bremers1, Cornelelis Verhoef23 and Johannes HW de Wilt1

Author Affiliations

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

2 Department of Surgery, IJsselland Hospital, Capelle aan de IJssel, The Netherlands

3 Department of Medical Oncology, Radboud University Nijmegen Medical Centre, The Netherlands

4 Department of Pathology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

5 Department of Radiation Oncology, Radboud University Nijmegen Medical Centre, The Netherlands

6 Department of Radiation Oncology, Erasmus Medical Centre, Rotterdam, The Netherlands

7 Department of Medical Oncology, Erasmus Medical Centre, Rotterdam, The Netherlands

8 Department of Surgery, Academic Medical Centre at the University of Amsterdam, Amsterdam, The Netherlands

9 Department of Surgery, Slotervaart Hospital, Amsterdam, The Netherlands

10 Department of Radiology, Erasmus Medical Centre, Rotterdam, The Netherlands

11 Department of Radiation Oncology, Leiden University Medical Centre, Leiden, The Netherlands

12 Department of Gastroenterology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands

13 Department of Surgery, Leiden University Medical Centre, Leiden, The Netherlands

14 Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands

15 Department of Surgery, Amphia Hospital, Breda, The Netherlands

16 Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands

17 Department of Surgery, Laurentius Hospital, Roermond, The Netherlands

18 Department of Radiation Oncology, Maastro Clinic, Maastricht, The Netherlands

19 Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands

20 Department of Surgery, Rijstate Hospital, Arnhem, The Netherlands

21 Department of Surgery, Diakonnessenhuis, Utrecht, The Netherlands

22 Department of Surgery, Medical Centre Leeuwarden, The Netherlands

23 Division of Surgical Oncology, Erasmus MC, Daniel den Hoed Cancer Center, Rotterdam, The Netherlands

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BMC Surgery 2011, 11:34  doi:10.1186/1471-2482-11-34

Published: 15 December 2011

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)