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

BMC Surg. 2011 Dec 15:11:34. doi: 10.1186/1471-2482-11-34.

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).

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / diagnosis
  • Adenocarcinoma / therapy*
  • Adult
  • Antineoplastic Agents / therapeutic use*
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Microsurgery / methods*
  • Middle Aged
  • Natural Orifice Endoscopic Surgery / methods*
  • Nose
  • Prospective Studies
  • Radiotherapy, Adjuvant
  • Rectal Neoplasms / diagnosis
  • Rectal Neoplasms / therapy*
  • Rectum / radiation effects
  • Rectum / surgery*
  • Treatment Outcome

Substances

  • Antineoplastic Agents

Associated data

  • ClinicalTrials.gov/NCT01273051