A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial
Abstract Background Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression...
Ausführliche Beschreibung
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| Autor*in: |
Nick J. Battersby [verfasserIn] Mit Dattani [verfasserIn] Sheela Rao [verfasserIn] David Cunningham [verfasserIn] Diana Tait [verfasserIn] Richard Adams [verfasserIn] Brendan J. Moran [verfasserIn] Shelize Khakoo [verfasserIn] Paris Tekkis [verfasserIn] Shahnawaz Rasheed [verfasserIn] Alex Mirnezami [verfasserIn] Philip Quirke [verfasserIn] Nicholas P. West [verfasserIn] Iris Nagtegaal [verfasserIn] Irene Chong [verfasserIn] Anguraj Sadanandam [verfasserIn] Nicola Valeri [verfasserIn] Karen Thomas [verfasserIn] Michelle Frost [verfasserIn] Gina Brown [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2017 |
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| Übergeordnetes Werk: |
In: Trials - BMC, 2006, 18(2017), 1, Seite 14 |
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| Übergeordnetes Werk: |
volume:18 ; year:2017 ; number:1 ; pages:14 |
| Links: |
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| DOI / URN: |
10.1186/s13063-017-2085-2 |
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| Katalog-ID: |
DOAJ001224468 |
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| 245 | 1 | 2 | |a A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial |
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| 520 | |a Abstract Background Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression occurs implying that no viable tumour is present within the surgical specimen. This raises the possibility that surgery may have been avoided. It is also recognised that response to CRT is a key determinant of prognosis. Recent radiological advances enable this response to be assessed pre-operatively using the MRI tumour regression grade (mrTRG). Potentially, this allows modification of the baseline MRI-derived treatment strategy. Hence, in a ‘good’ mrTRG responder, with little or no evidence of tumour, surgery may be deferred. Conversely, a ‘poor response’ identifies an adverse prognostic group which may benefit from additional pre-operative therapy. Methods/design TRIGGER is a multicentre, open, interventional, randomised control feasibility study with an embedded phase III design. Patients with MRI-defined, locally advanced rectal adenocarcinoma deemed to require CRT will be eligible for recruitment. During CRT, patients will be randomised (1:2) between conventional management, according to baseline MRI, versus mrTRG-directed management. The primary endpoint of the feasibility phase is to assess the rate of patient recruitment and randomisation. Secondary endpoints include the rate of unit recruitment, acute drug toxicity, reproducibility of mrTRG reporting, surgical morbidity, pathological circumferential resection margin involvement, pathology regression grade, residual tumour cell density and surgical/specimen quality rates. The phase III trial will focus on long-term safety, regrowth rates, oncological survival analysis, quality of life and health economics analysis. Discussion The TRIGGER trial aims to determine whether patients with locally advanced rectal cancer can be recruited and subsequently randomised into a control trial that offers MRI-directed patient management according to radiological response to CRT (mrTRG). The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection. Trial registration ClinicalTrials.gov, ID: NCT02704520 . Registered on 5 February 2016. | ||
| 650 | 4 | |a Randomised control trial | |
| 650 | 4 | |a Chemoradiotherapy | |
| 650 | 4 | |a Rectal cancer | |
| 650 | 4 | |a mrTRG | |
| 650 | 4 | |a Complete response | |
| 650 | 4 | |a Tumour regression | |
| 653 | 0 | |a Medicine (General) | |
| 700 | 0 | |a Mit Dattani |e verfasserin |4 aut | |
| 700 | 0 | |a Sheela Rao |e verfasserin |4 aut | |
| 700 | 0 | |a David Cunningham |e verfasserin |4 aut | |
| 700 | 0 | |a Diana Tait |e verfasserin |4 aut | |
| 700 | 0 | |a Richard Adams |e verfasserin |4 aut | |
| 700 | 0 | |a Brendan J. Moran |e verfasserin |4 aut | |
| 700 | 0 | |a Shelize Khakoo |e verfasserin |4 aut | |
| 700 | 0 | |a Paris Tekkis |e verfasserin |4 aut | |
| 700 | 0 | |a Shahnawaz Rasheed |e verfasserin |4 aut | |
| 700 | 0 | |a Alex Mirnezami |e verfasserin |4 aut | |
| 700 | 0 | |a Philip Quirke |e verfasserin |4 aut | |
| 700 | 0 | |a Nicholas P. West |e verfasserin |4 aut | |
| 700 | 0 | |a Iris Nagtegaal |e verfasserin |4 aut | |
| 700 | 0 | |a Irene Chong |e verfasserin |4 aut | |
| 700 | 0 | |a Anguraj Sadanandam |e verfasserin |4 aut | |
| 700 | 0 | |a Nicola Valeri |e verfasserin |4 aut | |
| 700 | 0 | |a Karen Thomas |e verfasserin |4 aut | |
| 700 | 0 | |a Michelle Frost |e verfasserin |4 aut | |
| 700 | 0 | |a Gina Brown |e verfasserin |4 aut | |
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10.1186/s13063-017-2085-2 doi (DE-627)DOAJ001224468 (DE-599)DOAJd33ef947bcf149739383193bb09a5f50 DE-627 ger DE-627 rakwb eng R5-920 Nick J. Battersby verfasserin aut A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression occurs implying that no viable tumour is present within the surgical specimen. This raises the possibility that surgery may have been avoided. It is also recognised that response to CRT is a key determinant of prognosis. Recent radiological advances enable this response to be assessed pre-operatively using the MRI tumour regression grade (mrTRG). Potentially, this allows modification of the baseline MRI-derived treatment strategy. Hence, in a ‘good’ mrTRG responder, with little or no evidence of tumour, surgery may be deferred. Conversely, a ‘poor response’ identifies an adverse prognostic group which may benefit from additional pre-operative therapy. Methods/design TRIGGER is a multicentre, open, interventional, randomised control feasibility study with an embedded phase III design. Patients with MRI-defined, locally advanced rectal adenocarcinoma deemed to require CRT will be eligible for recruitment. During CRT, patients will be randomised (1:2) between conventional management, according to baseline MRI, versus mrTRG-directed management. The primary endpoint of the feasibility phase is to assess the rate of patient recruitment and randomisation. Secondary endpoints include the rate of unit recruitment, acute drug toxicity, reproducibility of mrTRG reporting, surgical morbidity, pathological circumferential resection margin involvement, pathology regression grade, residual tumour cell density and surgical/specimen quality rates. The phase III trial will focus on long-term safety, regrowth rates, oncological survival analysis, quality of life and health economics analysis. Discussion The TRIGGER trial aims to determine whether patients with locally advanced rectal cancer can be recruited and subsequently randomised into a control trial that offers MRI-directed patient management according to radiological response to CRT (mrTRG). The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection. Trial registration ClinicalTrials.gov, ID: NCT02704520 . Registered on 5 February 2016. Randomised control trial Chemoradiotherapy Rectal cancer mrTRG Complete response Tumour regression Medicine (General) Mit Dattani verfasserin aut Sheela Rao verfasserin aut David Cunningham verfasserin aut Diana Tait verfasserin aut Richard Adams verfasserin aut Brendan J. Moran verfasserin aut Shelize Khakoo verfasserin aut Paris Tekkis verfasserin aut Shahnawaz Rasheed verfasserin aut Alex Mirnezami verfasserin aut Philip Quirke verfasserin aut Nicholas P. West verfasserin aut Iris Nagtegaal verfasserin aut Irene Chong verfasserin aut Anguraj Sadanandam verfasserin aut Nicola Valeri verfasserin aut Karen Thomas verfasserin aut Michelle Frost verfasserin aut Gina Brown verfasserin aut In Trials BMC, 2006 18(2017), 1, Seite 14 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:18 year:2017 number:1 pages:14 https://doi.org/10.1186/s13063-017-2085-2 kostenfrei https://doaj.org/article/d33ef947bcf149739383193bb09a5f50 kostenfrei http://link.springer.com/article/10.1186/s13063-017-2085-2 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 14 |
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10.1186/s13063-017-2085-2 doi (DE-627)DOAJ001224468 (DE-599)DOAJd33ef947bcf149739383193bb09a5f50 DE-627 ger DE-627 rakwb eng R5-920 Nick J. Battersby verfasserin aut A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression occurs implying that no viable tumour is present within the surgical specimen. This raises the possibility that surgery may have been avoided. It is also recognised that response to CRT is a key determinant of prognosis. Recent radiological advances enable this response to be assessed pre-operatively using the MRI tumour regression grade (mrTRG). Potentially, this allows modification of the baseline MRI-derived treatment strategy. Hence, in a ‘good’ mrTRG responder, with little or no evidence of tumour, surgery may be deferred. Conversely, a ‘poor response’ identifies an adverse prognostic group which may benefit from additional pre-operative therapy. Methods/design TRIGGER is a multicentre, open, interventional, randomised control feasibility study with an embedded phase III design. Patients with MRI-defined, locally advanced rectal adenocarcinoma deemed to require CRT will be eligible for recruitment. During CRT, patients will be randomised (1:2) between conventional management, according to baseline MRI, versus mrTRG-directed management. The primary endpoint of the feasibility phase is to assess the rate of patient recruitment and randomisation. Secondary endpoints include the rate of unit recruitment, acute drug toxicity, reproducibility of mrTRG reporting, surgical morbidity, pathological circumferential resection margin involvement, pathology regression grade, residual tumour cell density and surgical/specimen quality rates. The phase III trial will focus on long-term safety, regrowth rates, oncological survival analysis, quality of life and health economics analysis. Discussion The TRIGGER trial aims to determine whether patients with locally advanced rectal cancer can be recruited and subsequently randomised into a control trial that offers MRI-directed patient management according to radiological response to CRT (mrTRG). The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection. Trial registration ClinicalTrials.gov, ID: NCT02704520 . Registered on 5 February 2016. Randomised control trial Chemoradiotherapy Rectal cancer mrTRG Complete response Tumour regression Medicine (General) Mit Dattani verfasserin aut Sheela Rao verfasserin aut David Cunningham verfasserin aut Diana Tait verfasserin aut Richard Adams verfasserin aut Brendan J. Moran verfasserin aut Shelize Khakoo verfasserin aut Paris Tekkis verfasserin aut Shahnawaz Rasheed verfasserin aut Alex Mirnezami verfasserin aut Philip Quirke verfasserin aut Nicholas P. West verfasserin aut Iris Nagtegaal verfasserin aut Irene Chong verfasserin aut Anguraj Sadanandam verfasserin aut Nicola Valeri verfasserin aut Karen Thomas verfasserin aut Michelle Frost verfasserin aut Gina Brown verfasserin aut In Trials BMC, 2006 18(2017), 1, Seite 14 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:18 year:2017 number:1 pages:14 https://doi.org/10.1186/s13063-017-2085-2 kostenfrei https://doaj.org/article/d33ef947bcf149739383193bb09a5f50 kostenfrei http://link.springer.com/article/10.1186/s13063-017-2085-2 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 14 |
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10.1186/s13063-017-2085-2 doi (DE-627)DOAJ001224468 (DE-599)DOAJd33ef947bcf149739383193bb09a5f50 DE-627 ger DE-627 rakwb eng R5-920 Nick J. Battersby verfasserin aut A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression occurs implying that no viable tumour is present within the surgical specimen. This raises the possibility that surgery may have been avoided. It is also recognised that response to CRT is a key determinant of prognosis. Recent radiological advances enable this response to be assessed pre-operatively using the MRI tumour regression grade (mrTRG). Potentially, this allows modification of the baseline MRI-derived treatment strategy. Hence, in a ‘good’ mrTRG responder, with little or no evidence of tumour, surgery may be deferred. Conversely, a ‘poor response’ identifies an adverse prognostic group which may benefit from additional pre-operative therapy. Methods/design TRIGGER is a multicentre, open, interventional, randomised control feasibility study with an embedded phase III design. Patients with MRI-defined, locally advanced rectal adenocarcinoma deemed to require CRT will be eligible for recruitment. During CRT, patients will be randomised (1:2) between conventional management, according to baseline MRI, versus mrTRG-directed management. The primary endpoint of the feasibility phase is to assess the rate of patient recruitment and randomisation. Secondary endpoints include the rate of unit recruitment, acute drug toxicity, reproducibility of mrTRG reporting, surgical morbidity, pathological circumferential resection margin involvement, pathology regression grade, residual tumour cell density and surgical/specimen quality rates. The phase III trial will focus on long-term safety, regrowth rates, oncological survival analysis, quality of life and health economics analysis. Discussion The TRIGGER trial aims to determine whether patients with locally advanced rectal cancer can be recruited and subsequently randomised into a control trial that offers MRI-directed patient management according to radiological response to CRT (mrTRG). The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection. Trial registration ClinicalTrials.gov, ID: NCT02704520 . Registered on 5 February 2016. Randomised control trial Chemoradiotherapy Rectal cancer mrTRG Complete response Tumour regression Medicine (General) Mit Dattani verfasserin aut Sheela Rao verfasserin aut David Cunningham verfasserin aut Diana Tait verfasserin aut Richard Adams verfasserin aut Brendan J. Moran verfasserin aut Shelize Khakoo verfasserin aut Paris Tekkis verfasserin aut Shahnawaz Rasheed verfasserin aut Alex Mirnezami verfasserin aut Philip Quirke verfasserin aut Nicholas P. West verfasserin aut Iris Nagtegaal verfasserin aut Irene Chong verfasserin aut Anguraj Sadanandam verfasserin aut Nicola Valeri verfasserin aut Karen Thomas verfasserin aut Michelle Frost verfasserin aut Gina Brown verfasserin aut In Trials BMC, 2006 18(2017), 1, Seite 14 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:18 year:2017 number:1 pages:14 https://doi.org/10.1186/s13063-017-2085-2 kostenfrei https://doaj.org/article/d33ef947bcf149739383193bb09a5f50 kostenfrei http://link.springer.com/article/10.1186/s13063-017-2085-2 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 14 |
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10.1186/s13063-017-2085-2 doi (DE-627)DOAJ001224468 (DE-599)DOAJd33ef947bcf149739383193bb09a5f50 DE-627 ger DE-627 rakwb eng R5-920 Nick J. Battersby verfasserin aut A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression occurs implying that no viable tumour is present within the surgical specimen. This raises the possibility that surgery may have been avoided. It is also recognised that response to CRT is a key determinant of prognosis. Recent radiological advances enable this response to be assessed pre-operatively using the MRI tumour regression grade (mrTRG). Potentially, this allows modification of the baseline MRI-derived treatment strategy. Hence, in a ‘good’ mrTRG responder, with little or no evidence of tumour, surgery may be deferred. Conversely, a ‘poor response’ identifies an adverse prognostic group which may benefit from additional pre-operative therapy. Methods/design TRIGGER is a multicentre, open, interventional, randomised control feasibility study with an embedded phase III design. Patients with MRI-defined, locally advanced rectal adenocarcinoma deemed to require CRT will be eligible for recruitment. During CRT, patients will be randomised (1:2) between conventional management, according to baseline MRI, versus mrTRG-directed management. The primary endpoint of the feasibility phase is to assess the rate of patient recruitment and randomisation. Secondary endpoints include the rate of unit recruitment, acute drug toxicity, reproducibility of mrTRG reporting, surgical morbidity, pathological circumferential resection margin involvement, pathology regression grade, residual tumour cell density and surgical/specimen quality rates. The phase III trial will focus on long-term safety, regrowth rates, oncological survival analysis, quality of life and health economics analysis. Discussion The TRIGGER trial aims to determine whether patients with locally advanced rectal cancer can be recruited and subsequently randomised into a control trial that offers MRI-directed patient management according to radiological response to CRT (mrTRG). The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection. Trial registration ClinicalTrials.gov, ID: NCT02704520 . Registered on 5 February 2016. Randomised control trial Chemoradiotherapy Rectal cancer mrTRG Complete response Tumour regression Medicine (General) Mit Dattani verfasserin aut Sheela Rao verfasserin aut David Cunningham verfasserin aut Diana Tait verfasserin aut Richard Adams verfasserin aut Brendan J. Moran verfasserin aut Shelize Khakoo verfasserin aut Paris Tekkis verfasserin aut Shahnawaz Rasheed verfasserin aut Alex Mirnezami verfasserin aut Philip Quirke verfasserin aut Nicholas P. West verfasserin aut Iris Nagtegaal verfasserin aut Irene Chong verfasserin aut Anguraj Sadanandam verfasserin aut Nicola Valeri verfasserin aut Karen Thomas verfasserin aut Michelle Frost verfasserin aut Gina Brown verfasserin aut In Trials BMC, 2006 18(2017), 1, Seite 14 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:18 year:2017 number:1 pages:14 https://doi.org/10.1186/s13063-017-2085-2 kostenfrei https://doaj.org/article/d33ef947bcf149739383193bb09a5f50 kostenfrei http://link.springer.com/article/10.1186/s13063-017-2085-2 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 14 |
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Nick J. Battersby @@aut@@ Mit Dattani @@aut@@ Sheela Rao @@aut@@ David Cunningham @@aut@@ Diana Tait @@aut@@ Richard Adams @@aut@@ Brendan J. Moran @@aut@@ Shelize Khakoo @@aut@@ Paris Tekkis @@aut@@ Shahnawaz Rasheed @@aut@@ Alex Mirnezami @@aut@@ Philip Quirke @@aut@@ Nicholas P. West @@aut@@ Iris Nagtegaal @@aut@@ Irene Chong @@aut@@ Anguraj Sadanandam @@aut@@ Nicola Valeri @@aut@@ Karen Thomas @@aut@@ Michelle Frost @@aut@@ Gina Brown @@aut@@ |
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Nick J. Battersby Mit Dattani Sheela Rao David Cunningham Diana Tait Richard Adams Brendan J. Moran Shelize Khakoo Paris Tekkis Shahnawaz Rasheed Alex Mirnezami Philip Quirke Nicholas P. West Iris Nagtegaal Irene Chong Anguraj Sadanandam Nicola Valeri Karen Thomas Michelle Frost Gina Brown |
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rectal cancer feasibility study with an embedded phase iii trial design assessing magnetic resonance tumour regression grade (mrtrg) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (trigger): study protocol for a randomised controlled trial |
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A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial |
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Abstract Background Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression occurs implying that no viable tumour is present within the surgical specimen. This raises the possibility that surgery may have been avoided. It is also recognised that response to CRT is a key determinant of prognosis. Recent radiological advances enable this response to be assessed pre-operatively using the MRI tumour regression grade (mrTRG). Potentially, this allows modification of the baseline MRI-derived treatment strategy. Hence, in a ‘good’ mrTRG responder, with little or no evidence of tumour, surgery may be deferred. Conversely, a ‘poor response’ identifies an adverse prognostic group which may benefit from additional pre-operative therapy. Methods/design TRIGGER is a multicentre, open, interventional, randomised control feasibility study with an embedded phase III design. Patients with MRI-defined, locally advanced rectal adenocarcinoma deemed to require CRT will be eligible for recruitment. During CRT, patients will be randomised (1:2) between conventional management, according to baseline MRI, versus mrTRG-directed management. The primary endpoint of the feasibility phase is to assess the rate of patient recruitment and randomisation. Secondary endpoints include the rate of unit recruitment, acute drug toxicity, reproducibility of mrTRG reporting, surgical morbidity, pathological circumferential resection margin involvement, pathology regression grade, residual tumour cell density and surgical/specimen quality rates. The phase III trial will focus on long-term safety, regrowth rates, oncological survival analysis, quality of life and health economics analysis. Discussion The TRIGGER trial aims to determine whether patients with locally advanced rectal cancer can be recruited and subsequently randomised into a control trial that offers MRI-directed patient management according to radiological response to CRT (mrTRG). The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection. Trial registration ClinicalTrials.gov, ID: NCT02704520 . Registered on 5 February 2016. |
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Abstract Background Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression occurs implying that no viable tumour is present within the surgical specimen. This raises the possibility that surgery may have been avoided. It is also recognised that response to CRT is a key determinant of prognosis. Recent radiological advances enable this response to be assessed pre-operatively using the MRI tumour regression grade (mrTRG). Potentially, this allows modification of the baseline MRI-derived treatment strategy. Hence, in a ‘good’ mrTRG responder, with little or no evidence of tumour, surgery may be deferred. Conversely, a ‘poor response’ identifies an adverse prognostic group which may benefit from additional pre-operative therapy. Methods/design TRIGGER is a multicentre, open, interventional, randomised control feasibility study with an embedded phase III design. Patients with MRI-defined, locally advanced rectal adenocarcinoma deemed to require CRT will be eligible for recruitment. During CRT, patients will be randomised (1:2) between conventional management, according to baseline MRI, versus mrTRG-directed management. The primary endpoint of the feasibility phase is to assess the rate of patient recruitment and randomisation. Secondary endpoints include the rate of unit recruitment, acute drug toxicity, reproducibility of mrTRG reporting, surgical morbidity, pathological circumferential resection margin involvement, pathology regression grade, residual tumour cell density and surgical/specimen quality rates. The phase III trial will focus on long-term safety, regrowth rates, oncological survival analysis, quality of life and health economics analysis. Discussion The TRIGGER trial aims to determine whether patients with locally advanced rectal cancer can be recruited and subsequently randomised into a control trial that offers MRI-directed patient management according to radiological response to CRT (mrTRG). The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection. Trial registration ClinicalTrials.gov, ID: NCT02704520 . Registered on 5 February 2016. |
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Abstract Background Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression occurs implying that no viable tumour is present within the surgical specimen. This raises the possibility that surgery may have been avoided. It is also recognised that response to CRT is a key determinant of prognosis. Recent radiological advances enable this response to be assessed pre-operatively using the MRI tumour regression grade (mrTRG). Potentially, this allows modification of the baseline MRI-derived treatment strategy. Hence, in a ‘good’ mrTRG responder, with little or no evidence of tumour, surgery may be deferred. Conversely, a ‘poor response’ identifies an adverse prognostic group which may benefit from additional pre-operative therapy. Methods/design TRIGGER is a multicentre, open, interventional, randomised control feasibility study with an embedded phase III design. Patients with MRI-defined, locally advanced rectal adenocarcinoma deemed to require CRT will be eligible for recruitment. During CRT, patients will be randomised (1:2) between conventional management, according to baseline MRI, versus mrTRG-directed management. The primary endpoint of the feasibility phase is to assess the rate of patient recruitment and randomisation. Secondary endpoints include the rate of unit recruitment, acute drug toxicity, reproducibility of mrTRG reporting, surgical morbidity, pathological circumferential resection margin involvement, pathology regression grade, residual tumour cell density and surgical/specimen quality rates. The phase III trial will focus on long-term safety, regrowth rates, oncological survival analysis, quality of life and health economics analysis. Discussion The TRIGGER trial aims to determine whether patients with locally advanced rectal cancer can be recruited and subsequently randomised into a control trial that offers MRI-directed patient management according to radiological response to CRT (mrTRG). The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection. Trial registration ClinicalTrials.gov, ID: NCT02704520 . Registered on 5 February 2016. |
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The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection. Trial registration ClinicalTrials.gov, ID: NCT02704520 . 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