Cargando…
CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer
BACKGROUND: Current evidence supports a diverting stoma in patients undergoing low anterior resection with total mesorectal excision for rectal cancer as it reduces clinical severity of anastomotic leakage. However, relevant stoma morbidity after rectal cancer surgery exists and has a significant im...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4654836/ https://www.ncbi.nlm.nih.gov/pubmed/26589718 http://dx.doi.org/10.1186/s12885-015-1838-0 |
_version_ | 1782402109771087872 |
---|---|
author | Sandra-Petrescu, Flavius Herrle, Florian Hinke, Axel Rossion, Inga Suelberg, Heiko Post, Stefan Hofheinz, Ralf-Dieter Kienle, Peter |
author_facet | Sandra-Petrescu, Flavius Herrle, Florian Hinke, Axel Rossion, Inga Suelberg, Heiko Post, Stefan Hofheinz, Ralf-Dieter Kienle, Peter |
author_sort | Sandra-Petrescu, Flavius |
collection | PubMed |
description | BACKGROUND: Current evidence supports a diverting stoma in patients undergoing low anterior resection with total mesorectal excision for rectal cancer as it reduces clinical severity of anastomotic leakage. However, relevant stoma morbidity after rectal cancer surgery exists and has a significant impact on quality of life. Moreover, a diverting stoma has an influence on completeness of chemotherapy but it remains unclear in which way. There is no evidence regarding optimal timing for stoma closure in relation to adjuvant chemotherapy. Two randomised controlled trials have studied early stoma closure after low anterior resection in patients with rectal cancer, one of them showing that early closure around day 8 after resection is possible without increasing morbidity. METHODS/DESIGN: CoCStom is a randomised multicentre trial comparing completeness of adjuvant chemotherapy as primary endpoint after early (8–10 days after resection, before starting adjuvant therapy) versus late (~26 weeks after resection and completion of adjuvant therapy) stoma closure in patients with locally advanced rectal cancer undergoing low anterior resection after neoadjuvant therapy. After exclusion of post-operative anastomotic leakage 257 patients from 30 German hospitals are planned to be included in order to assure a power of 80 % for the confirmatory analysis of at least 214 evaluable cases. An absolute increase of 20 % for the rate of completely administered adjuvant chemotherapy is regarded as a clinically meaningful step forward and serves as basis for sample size calculation. Quality of life, stoma-related complications, individual completeness of chemotherapy rate, percentage of patients stopping adjuvant therapy or undergoing dose modifications or delay, oncological outcomes, cumulative days of hospitalisation and number of readmissions, rate of symptomatic anastomotic leaks after stoma closure, mortality, post-operative complications and toxicity of adjuvant chemotherapy are secondary endpoints. DISCUSSION: The CoCStom trial aims to clarify optimal timing of stoma closure in the context of adjuvant chemotherapy. Depending on the results of the trial, patients could benefit either from early or late stoma closure in regard to long term oncological survival due to a higher rate of completeness of adjuvant chemotherapy treatment and thus better effectiveness. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00005113. Registered 28 August 2013 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12885-015-1838-0) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4654836 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-46548362015-11-22 CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer Sandra-Petrescu, Flavius Herrle, Florian Hinke, Axel Rossion, Inga Suelberg, Heiko Post, Stefan Hofheinz, Ralf-Dieter Kienle, Peter BMC Cancer Study Protocol BACKGROUND: Current evidence supports a diverting stoma in patients undergoing low anterior resection with total mesorectal excision for rectal cancer as it reduces clinical severity of anastomotic leakage. However, relevant stoma morbidity after rectal cancer surgery exists and has a significant impact on quality of life. Moreover, a diverting stoma has an influence on completeness of chemotherapy but it remains unclear in which way. There is no evidence regarding optimal timing for stoma closure in relation to adjuvant chemotherapy. Two randomised controlled trials have studied early stoma closure after low anterior resection in patients with rectal cancer, one of them showing that early closure around day 8 after resection is possible without increasing morbidity. METHODS/DESIGN: CoCStom is a randomised multicentre trial comparing completeness of adjuvant chemotherapy as primary endpoint after early (8–10 days after resection, before starting adjuvant therapy) versus late (~26 weeks after resection and completion of adjuvant therapy) stoma closure in patients with locally advanced rectal cancer undergoing low anterior resection after neoadjuvant therapy. After exclusion of post-operative anastomotic leakage 257 patients from 30 German hospitals are planned to be included in order to assure a power of 80 % for the confirmatory analysis of at least 214 evaluable cases. An absolute increase of 20 % for the rate of completely administered adjuvant chemotherapy is regarded as a clinically meaningful step forward and serves as basis for sample size calculation. Quality of life, stoma-related complications, individual completeness of chemotherapy rate, percentage of patients stopping adjuvant therapy or undergoing dose modifications or delay, oncological outcomes, cumulative days of hospitalisation and number of readmissions, rate of symptomatic anastomotic leaks after stoma closure, mortality, post-operative complications and toxicity of adjuvant chemotherapy are secondary endpoints. DISCUSSION: The CoCStom trial aims to clarify optimal timing of stoma closure in the context of adjuvant chemotherapy. Depending on the results of the trial, patients could benefit either from early or late stoma closure in regard to long term oncological survival due to a higher rate of completeness of adjuvant chemotherapy treatment and thus better effectiveness. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00005113. Registered 28 August 2013 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12885-015-1838-0) contains supplementary material, which is available to authorized users. BioMed Central 2015-11-21 /pmc/articles/PMC4654836/ /pubmed/26589718 http://dx.doi.org/10.1186/s12885-015-1838-0 Text en © Sandra-Petrescu et al. 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Sandra-Petrescu, Flavius Herrle, Florian Hinke, Axel Rossion, Inga Suelberg, Heiko Post, Stefan Hofheinz, Ralf-Dieter Kienle, Peter CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer |
title | CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer |
title_full | CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer |
title_fullStr | CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer |
title_full_unstemmed | CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer |
title_short | CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer |
title_sort | cocstom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4654836/ https://www.ncbi.nlm.nih.gov/pubmed/26589718 http://dx.doi.org/10.1186/s12885-015-1838-0 |
work_keys_str_mv | AT sandrapetrescuflavius cocstomtrialstudyprotocolforarandomisedtrialcomparingcompletenessofadjuvantchemotherapyafterearlyversuslatedivertingstomaclosureinlowanteriorresectionforrectalcancer AT herrleflorian cocstomtrialstudyprotocolforarandomisedtrialcomparingcompletenessofadjuvantchemotherapyafterearlyversuslatedivertingstomaclosureinlowanteriorresectionforrectalcancer AT hinkeaxel cocstomtrialstudyprotocolforarandomisedtrialcomparingcompletenessofadjuvantchemotherapyafterearlyversuslatedivertingstomaclosureinlowanteriorresectionforrectalcancer AT rossioninga cocstomtrialstudyprotocolforarandomisedtrialcomparingcompletenessofadjuvantchemotherapyafterearlyversuslatedivertingstomaclosureinlowanteriorresectionforrectalcancer AT suelbergheiko cocstomtrialstudyprotocolforarandomisedtrialcomparingcompletenessofadjuvantchemotherapyafterearlyversuslatedivertingstomaclosureinlowanteriorresectionforrectalcancer AT poststefan cocstomtrialstudyprotocolforarandomisedtrialcomparingcompletenessofadjuvantchemotherapyafterearlyversuslatedivertingstomaclosureinlowanteriorresectionforrectalcancer AT hofheinzralfdieter cocstomtrialstudyprotocolforarandomisedtrialcomparingcompletenessofadjuvantchemotherapyafterearlyversuslatedivertingstomaclosureinlowanteriorresectionforrectalcancer AT kienlepeter cocstomtrialstudyprotocolforarandomisedtrialcomparingcompletenessofadjuvantchemotherapyafterearlyversuslatedivertingstomaclosureinlowanteriorresectionforrectalcancer |