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

Abstract

BackgroundThe CARTS study is a multicenter feasibility study, investigating the role of rectum saving surgery for distal rectal cancer.Methods/DesignPatients 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.DiscussionThe 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)

Paradigm Shift in the Management of Rectal Cancer

“…Whilst TME/ELAPE surgery is now an accepted standard of care in rectal cancer surgery, how this is performed has evolved with advances in laparoscopic and robotic equipment and expertise. Whether all patients with rectal cancer should be treated by TME/ELAPE surgery has also been questioned [10,[44][45][46]. There is concern that for selected patients with early stage disease, complete excision of the rectum and mesorectal envelope may represent overtreatment of the cancer and expose the patient to unnecessary morbidity, if cure could be achieved without such a radical surgical approach.…”

“…There are two currently recruiting trials (CARTS [44] and the UK TREC trial [45]) that may extend the use of TEMS with neoadjuvant treatment beyond the treatment of early rectal cancer, both are evaluating the role of TEMS for advanced tumours by comparing preoperative chemoradiotherapy followed by TEMS excision with conventional TME surgery.…”

Transanal Endoscopic Microsurgery

“…TEM of more advanced rectal cancer remains a controversial issue. However TEM has recently become a more attractive option because of the regular use of neoadjuvant therapy at several centers [4,5,[8][9][10][11][12][13]. Still other indications have also been described: repair of high or supralevator fistulas, rectourethral fistulas and rectal prolapse, drainage of pelvic collections, impacted fecaloma and excision of extra rectal masses [5,[14][15][16].…”

“…TEM has been shown to be superior to transanal excision (TAE) for benign and malignant rectal neoplasms. There is a significantly lower risk of fragmented of piecemeal excision, incomplete resection and consequently a lower recurrence rate [4,[6][7][8]. TEM of more advanced rectal cancer remains a controversial issue.…”

“…By using an operating rectoscope with a diameter of 4 cm and a length of 12 or 20 cm is used the most challenging aspect of transanal surgery, reaching the cephalad margins, is easily achieved. The scope has four work channels, a stereo optic vision channel, a light source, and an insufflations port to obtain a pneumorectum for maximum exposure [4,5]. TEM has been shown to be superior to transanal excision (TAE) for benign and malignant rectal neoplasms.…”