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).
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).
Authors: R Hughes; R Glynne-Jones; J Grainger; P Richman; A Makris; M Harrison; R Ashford; R A Harrison; J I Livingstone; P J McDonald; J Meyrick Thomas; I C Mitchell; J M A Northover; R Phillips; M Wallace; A Windsor; J R Novell Journal: Int J Colorectal Dis Date: 2005-04-30 Impact factor: 2.571
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Authors: Rutger C H Stijns; Eelco J R de Graaf; Cornelis J A Punt; Iris D Nagtegaal; Joost J M E Nuyttens; Esther van Meerten; Pieter J Tanis; Ignace H J T de Hingh; George P van der Schelling; Yair Acherman; Jeroen W A Leijtens; Andreas J A Bremers; Geerard L Beets; Christiaan Hoff; Cornelis Verhoef; Corrie A M Marijnen; Johannes H W de Wilt Journal: JAMA Surg Date: 2019-01-01 Impact factor: 14.766