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

Guus M. J. Bokkerink; Eelco J. R. de Graaf; Cornelis J. A. Punt; Iris D. Nagtegaal; Heidi Rütten; Joost J. M. E. Nuyttens; Esther van Meerten; Pascal G. Doornebosch; Pieter J. Tanis; Eric J. Derksen; Roy S. Dwarkasing; Corrie A. M. Marijnen; Annemieke Cats; Rob A. E. M. Tollenaar; Ignace H. J. T. de Hingh; Harm J. T. Rutten; George P. van der Schelling; Albert J. ten Tije; Jeroen W. A. Leijtens; Guido Lammering; Geerard L. Beets; Theo J. Aufenacker; Apollo Pronk; Eric R. Manusama; Christiaan Hoff; Andreas J. A. Bremers; Cornelelis Verhoef; Johannes H. W. de Wilt

doi:https://doi.org/10.1186/1471-2482-11-34

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

Guus M. J. Bokkerink, Eelco J. R. de Graaf, Cornelis J. A. Punt, Iris D. Nagtegaal, Heidi Rütten, Joost J. M. E. Nuyttens, Esther van Meerten, Pascal G. Doornebosch, Pieter J. Tanis, Eric J. Derksen, Roy S. Dwarkasing, Corrie A. M. Marijnen, Annemieke Cats, Rob A. E. M. Tollenaar, Ignace H. J. T. de Hingh, Harm J. T. Rutten, George P. van der Schelling, Albert J. ten Tije, Jeroen W. A. Leijtens, Guido LammeringGeerard L. Beets, Theo J. Aufenacker, Apollo Pronk, Eric R. Manusama, Christiaan Hoff, Andreas J. A. Bremers, Cornelelis Verhoef, Johannes H. W. de Wilt

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Abstract

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)

Original language	English
Pages (from-to)	34
Journal	BMC Surgery
Volume	11
Issue number	1
DOIs	https://doi.org/10.1186/1471-2482-11-34
Publication status	Published - 2011

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https://doi.org/10.1186/1471-2482-11-34

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Bokkerink, G. M. J., de Graaf, E. J. R., Punt, C. J. A., Nagtegaal, I. D., Rütten, H., Nuyttens, J. J. M. E., van Meerten, E., Doornebosch, P. G., Tanis, P. J., Derksen, E. J., Dwarkasing, R. S., Marijnen, C. A. M., Cats, A., Tollenaar, R. A. E. M., de Hingh, I. H. J. T., Rutten, H. J. T., van der Schelling, G. P., ten Tije, A. J., Leijtens, J. W. A., ... de Wilt, J. H. W. (2011). The CARTS study: Chemoradiation therapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery. BMC Surgery, 11(1), 34. https://doi.org/10.1186/1471-2482-11-34

@article{c91ed2491e3c407393d84224fb117f41,

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

abstract = "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)",

author = "Bokkerink, {Guus M. J.} and {de Graaf}, {Eelco J. R.} and Punt, {Cornelis J. A.} and Nagtegaal, {Iris D.} and Heidi R{\"u}tten and Nuyttens, {Joost J. M. E.} and {van Meerten}, Esther and Doornebosch, {Pascal G.} and Tanis, {Pieter J.} and Derksen, {Eric J.} and Dwarkasing, {Roy S.} and Marijnen, {Corrie A. M.} and Annemieke Cats and Tollenaar, {Rob A. E. M.} and {de Hingh}, {Ignace H. J. T.} and Rutten, {Harm J. T.} and {van der Schelling}, {George P.} and {ten Tije}, {Albert J.} and Leijtens, {Jeroen W. A.} and Guido Lammering and Beets, {Geerard L.} and Aufenacker, {Theo J.} and Apollo Pronk and Manusama, {Eric R.} and Christiaan Hoff and Bremers, {Andreas J. A.} and Cornelelis Verhoef and {de Wilt}, {Johannes H. W.}",

year = "2011",

doi = "https://doi.org/10.1186/1471-2482-11-34",

language = "English",

volume = "11",

pages = "34",

journal = "BMC Surgery",

issn = "1471-2482",

publisher = "BioMed Central",

number = "1",

}

Bokkerink, GMJ, de Graaf, EJR, Punt, CJA, Nagtegaal, ID, Rütten, H, Nuyttens, JJME, van Meerten, E, Doornebosch, PG, Tanis, PJ, Derksen, EJ, Dwarkasing, RS, Marijnen, CAM, Cats, A, Tollenaar, RAEM, de Hingh, IHJT, Rutten, HJT, van der Schelling, GP, ten Tije, AJ, Leijtens, JWA, Lammering, G, Beets, GL, Aufenacker, TJ, Pronk, A, Manusama, ER, Hoff, C, Bremers, AJA, Verhoef, C & de Wilt, JHW 2011, 'The CARTS study: Chemoradiation therapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery', BMC Surgery, vol. 11, no. 1, pp. 34. https://doi.org/10.1186/1471-2482-11-34

TY - JOUR

T1 - The CARTS study: Chemoradiation therapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery

AU - Bokkerink, Guus M. J.

AU - de Graaf, Eelco J. R.

AU - Punt, Cornelis J. A.

AU - Nagtegaal, Iris D.

AU - Rütten, Heidi

AU - Nuyttens, Joost J. M. E.

AU - van Meerten, Esther

AU - Doornebosch, Pascal G.

AU - Tanis, Pieter J.

AU - Derksen, Eric J.

AU - Dwarkasing, Roy S.

AU - Marijnen, Corrie A. M.

AU - Cats, Annemieke

AU - Tollenaar, Rob A. E. M.

AU - de Hingh, Ignace H. J. T.

AU - Rutten, Harm J. T.

AU - van der Schelling, George P.

AU - ten Tije, Albert J.

AU - Leijtens, Jeroen W. A.

AU - Lammering, Guido

AU - Beets, Geerard L.

AU - Aufenacker, Theo J.

AU - Pronk, Apollo

AU - Manusama, Eric R.

AU - Hoff, Christiaan

AU - Bremers, Andreas J. A.

AU - Verhoef, Cornelelis

AU - de Wilt, Johannes H. W.

PY - 2011

Y1 - 2011

N2 - 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)

AB - 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)

U2 - https://doi.org/10.1186/1471-2482-11-34

DO - https://doi.org/10.1186/1471-2482-11-34

M3 - Article

C2 - 22171697

SN - 1471-2482

VL - 11

SP - 34

JO - BMC Surgery

JF - BMC Surgery

IS - 1

ER -