BMC Surgery (Dec 2011)

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

  • Bökkerink Guus MJ,
  • de Graaf Eelco JR,
  • Punt Cornelis JA,
  • Nagtegaal Iris D,
  • Rütten Heidi,
  • Nuyttens Joost JME,
  • van Meerten Esther,
  • Doornebosch Pascal G,
  • Tanis Pieter J,
  • Derksen Eric J,
  • Dwarkasing Roy S,
  • Marijnen Corrie AM,
  • Cats Annemieke,
  • Tollenaar Rob AEM,
  • de Hingh Ignace HJT,
  • Rutten Harm JT,
  • van der Schelling George P,
  • ten Tije Albert J,
  • Leijtens Jeroen WA,
  • Lammering Guido,
  • Beets Geerard L,
  • Aufenacker Theo J,
  • Pronk Apollo,
  • Manusama Eric R,
  • Hoff Christiaan,
  • Bremers Andreas JA,
  • Verhoef Cornelelis,
  • de Wilt Johannes HW

DOI
https://doi.org/10.1186/1471-2482-11-34
Journal volume & issue
Vol. 11, no. 1
p. 34

Abstract

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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)