title: The CARTS study: Chemoradiation therapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery.
abstract: BACKGROUND
  The CARTS study is a multicenter feasibility study, investigating the role of rectum saving surgery for distal rectal cancer.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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).
authors.affiliation: Department of Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. g.bokkerink@chir.umcn.nl
authors.forename: Guus M J
authors.initials: GM
authors.lastname: Bökkerink
authors.forename: Eelco J R
authors.initials: EJ
authors.lastname: de Graaf
authors.forename: Cornelis J A
authors.initials: CJ
authors.lastname: Punt
authors.forename: Iris D
authors.initials: ID
authors.lastname: Nagtegaal
authors.forename: Heidi
authors.initials: H
authors.lastname: Rütten
authors.forename: Joost J M E
authors.initials: JJ
authors.lastname: Nuyttens
authors.forename: Esther
authors.initials: E
authors.lastname: van Meerten
authors.forename: Pascal G
authors.initials: PG
authors.lastname: Doornebosch
authors.forename: Pieter J
authors.initials: PJ
authors.lastname: Tanis
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Derksen
authors.forename: Roy S
authors.initials: RS
authors.lastname: Dwarkasing
authors.forename: Corrie A M
authors.initials: CA
authors.lastname: Marijnen
authors.forename: Annemieke
authors.initials: A
authors.lastname: Cats
authors.forename: Rob A E M
authors.initials: RA
authors.lastname: Tollenaar
authors.forename: Ignace H J T
authors.initials: IH
authors.lastname: de Hingh
authors.forename: Harm J T
authors.initials: HJ
authors.lastname: Rutten
authors.forename: George P
authors.initials: GP
authors.lastname: van der Schelling
authors.forename: Albert J
authors.initials: AJ
authors.lastname: Ten Tije
authors.forename: Jeroen W A
authors.initials: JW
authors.lastname: Leijtens
authors.forename: Guido
authors.initials: G
authors.lastname: Lammering
authors.forename: Geerard L
authors.initials: GL
authors.lastname: Beets
authors.forename: Theo J
authors.initials: TJ
authors.lastname: Aufenacker
authors.forename: Apollo
authors.initials: A
authors.lastname: Pronk
authors.forename: Eric R
authors.initials: ER
authors.lastname: Manusama
authors.forename: Christiaan
authors.initials: C
authors.lastname: Hoff
authors.forename: Andreas J A
authors.initials: AJ
authors.lastname: Bremers
authors.forename: Cornelelis
authors.initials: C
authors.lastname: Verhoef
authors.forename: Johannes H W
authors.initials: JH
authors.lastname: de Wilt
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis / Q000628:therapy*; D000328:Adult; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008866:Microsurgery / Q000379:methods*; D008875:Middle Aged; D057605:Natural Orifice Endoscopic Surgery / Q000379:methods*; D009666:Nose; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D012004:Rectal Neoplasms / Q000175:diagnosis / Q000628:therapy*; D012007:Rectum / Q000528:radiation effects / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents