Birtle, Alison

Bryan, Richard

Catto, James

Chester, John

Donovan, Jenny

Hall, Emma

Johnson, Mark

Jones, E

Jones, Robert

Kockelbergh, Roger

Lewis, Rebecca

Powles, Thomas

European Urology Supplements

University of Birmingham Research Portal

  Peri-operative chemotherapy or surveillance inupper tract urothelial cancer (POUT - CRUK/11/027)- a randomised controlled trial to define standardpost-operative managementBirtle, Alison; Lewis, Rebecca; Chester, John; Donovan, Jenny; Johnson, Mark; Jones,Robert; Kockelbergh, Roger; Powles, Thomas; Bryan, Richard; Catto, James; Jones, E; Hall,EmmaDOI:10.1016/S1569-9056(13)60573-4Citation for published version (Harvard):Birtle, A, Lewis, R, Chester, J, Donovan, J, Johnson, M, Jones, R, Kockelbergh, R, Powles, T, Bryan, R, Catto,J, Jones, E & Hall, E 2013, Peri-operative chemotherapy or surveillance in upper tract urothelial cancer (POUT -CRUK/11/027) - a randomised controlled trial to define standard post-operative management. in EuropeanUrology Supplements: 28th Annual Congress of the European Association of Urology Abstracts. 1 edn, vol. 12,pp. e81-e82, 28th Annual European Association of Urology Congress, Milan, Italy, 15/03/13.https://doi.org/10.1016/S1569-9056(13)60573-4Link to publication on Research at Birmingham portalGeneral rightsUnless a licence is specified above, all rights (including copyright and moral rights) in this document are retained by the authors and/or thecopyright holders. The express permission of the copyright holder must be obtained for any use of this material other than for purposespermitted by law.•	Users may freely distribute the URL that is used to identify this publication.•	Users may download and/or print one copy of the publication from the University of Birmingham research portal for the purpose of privatestudy or non-commercial research.•	User may use extracts from the document in line with the concept of ‘fair dealing’ under the Copyright, Designs and Patents Act 1988 (?)•	Users may not further distribute the material nor use it for the purposes of commercial gain.Where a licence is displayed above, please note the terms and conditions of the licence govern your use of this document.When citing, please reference the published version.Take down policyWhile the University of Birmingham exercises care and attention in making items available there are rare occasions when an item has beenuploaded in error or has been deemed to be commercially or otherwise sensitive.If you believe that this is the case for this document, please contact UBIRA@lists.bham.ac.uk providing details and we will remove access tothe work immediately and investigate.Download date: 01. Feb. 2019Birtle A.1, Lewis R.2, Chester J.3, Donovan J.4, Johnson M.5, Jones R.6, Kockelbergh R.7, Powles T.8, Bryan R.9, Catto J.10, Jones E.2, Hall E.21Lancashire Teaching Hospitals Nhs Foundation Trust, Rosemere Cancer Centre, Preston, United Kingdom, 2Institute of Cancer Research (ICR), ICR Clinical Trials and Statistics Unit (ICR-CTSU), Surrey, United Kingdom, 3Cardiff University, Velindre Hospital, Cardiff, United Kingdom, 4University of Bristol, School of Social and Community Medicine, Bristol, United Kingdom, 5The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle, United Kingdom, 6NHS Greater Glasgow and Clyde, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, 7University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary, Leicester, United Kingdom, 8Barts Health NHS Trust, St Barts Hospital, London, United Kingdom, 9University of Birmingham, The School of Cancer Sciences, Birmingham, United Kingdom, 10Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Sheffield, United KingdomINTRODUCTION & OBJECTIVES: The POUT trial aims to establish whether platinum-based combination chemotherapy is superior to surveillance following nephro-ureterectomy with curative intent for upper tract transitional cell carcinoma (utTCC). POUT opened to recruitment in the UK on 31/05/2012, with the aim to randomise 345 participants world-wide over a 5-year period. The trial incorporates an initial 2 year recruitment optimisation phase, with qualitative research exploring issues relating to the recruitment process and targets relating to patient recruitment and the number of centres open. Initial milestones are: 9 centres open within 6 months of first centre opening, 18 centres open within first 12 months, and 22 patients recruited within the first 12 months.MATERIAL & METHODS: Previous trials of adjuvant chemotherapy for urothelial cancers suggest that potential challenges to recruitment include randomisation between “no treatment” vs chemotherapy with its potential toxicity, and early identification of eligible patients. To ensure trial design was pragmatic and consistent with current practice we conducted a survey of participating UK centres. Prior to regulatory submissions a dedicated patient focus group with those who had experience of utTCC met to ensure the trial was relevant to patients and to further develop patient documentation.RESULTS: 31 of 53 responding UK centres routinely place utTCC patients on surveillance following nephro-ureterectomy; 22 give chemotherapy if the patient is considered fit enough. The 13 respondents who specified chemotherapy regimens give gemcitabine and cisplatin or carboplatin, dependent on renal function. All centres discuss patients pre-operatively in a multi-disciplinary team meeting, but 7 centres do not routinely discuss patients post-operatively. The patient group welcomed the opportunity for utTCC patients to participate in research. They approved of the proposed randomisation between surveillance and chemotherapy and supported the use of a two stage pre- and 81 Peri-operative chemotherapy or surveillance in upper tract urothelial cancer (POUT - CRUK/11/027) - a randomised controlled trial to define standard post-operative managementEur Urol Suppl 2013;12;e81post-operative information giving process. Initial milestones relating to number of sites have been reached within 4 months of opening the trial and accrual is currently on target to meet the initial recruitment milestone.CONCLUSIONS: There is no consensus among UK clinicians regarding optimum post-operative treatment of muscle invasive utTCC. The POUT trial offers the opportunity to standardise post-operative management of utTCC internationally and is supported by urologists, oncologists and patient representatives from the target population. To optimise clinical impact and deliver overall target recruitment within timelines, international recruitment is planned. An initial POUT European collaborators meeting will be held at the 28th Annual EAU Congress, for further information contact POUT-icrctsu@icr.ac.uk.

Peri-operative chemotherapy or surveillance in upper tract urothelial cancer (POUT - CRUK/11/027) - a randomised controlled trial to define standard post-operative management

  University of BirminghamPeri-operative chemotherapy or surveillance inupper tract urothelial cancer (POUT - CRUK/11/027)- a randomised controlled trial to define standardpost-operative managementBirtle, Alison; Lewis, Rebecca; Chester, John; Donovan, Jenny; Johnson, Mark; Jones,Robert; Kockelbergh, Roger; Powles, Thomas; Bryan, Richard; Catto, James; Jones, E; Hall,EmmaDOI:10.1016/S1569-9056(13)60573-4Citation for published version (Harvard):Birtle, A, Lewis, R, Chester, J, Donovan, J, Johnson, M, Jones, R, Kockelbergh, R, Powles, T, Bryan, R, Catto,J, Jones, E & Hall, E 2013, Peri-operative chemotherapy or surveillance in upper tract urothelial cancer (POUT -CRUK/11/027) - a randomised controlled trial to define standard post-operative management. in EuropeanUrology Supplements: 28th Annual Congress of the European Association of Urology Abstracts. 1 edn, vol. 12,pp. e81-e82, 28th Annual European Association of Urology Congress, Milan, Italy, 15/03/13.https://doi.org/10.1016/S1569-9056(13)60573-4Link to publication on Research at Birmingham portalGeneral rightsUnless a licence is specified above, all rights (including copyright and moral rights) in this document are retained by the authors and/or thecopyright holders. The express permission of the copyright holder must be obtained for any use of this material other than for purposespermitted by law.•	Users may freely distribute the URL that is used to identify this publication.•	Users may download and/or print one copy of the publication from the University of Birmingham research portal for the purpose of privatestudy or non-commercial research.•	User may use extracts from the document in line with the concept of ‘fair dealing’ under the Copyright, Designs and Patents Act 1988 (?)•	Users may not further distribute the material nor use it for the purposes of commercial gain.Where a licence is displayed above, please note the terms and conditions of the licence govern your use of this document.When citing, please reference the published version.Take down policyWhile the University of Birmingham exercises care and attention in making items available there are rare occasions when an item has beenuploaded in error or has been deemed to be commercially or otherwise sensitive.If you believe that this is the case for this document, please contact UBIRA@lists.bham.ac.uk providing details and we will remove access tothe work immediately and investigate.Download date: 01. Mar. 2020Birtle A.1, Lewis R.2, Chester J.3, Donovan J.4, Johnson M.5, Jones R.6, Kockelbergh R.7, Powles T.8, Bryan R.9, Catto J.10, Jones E.2, Hall E.21Lancashire Teaching Hospitals Nhs Foundation Trust, Rosemere Cancer Centre, Preston, United Kingdom, 2Institute of Cancer Research (ICR), ICR Clinical Trials and Statistics Unit (ICR-CTSU), Surrey, United Kingdom, 3Cardiff University, Velindre Hospital, Cardiff, United Kingdom, 4University of Bristol, School of Social and Community Medicine, Bristol, United Kingdom, 5The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle, United Kingdom, 6NHS Greater Glasgow and Clyde, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, 7University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary, Leicester, United Kingdom, 8Barts Health NHS Trust, St Barts Hospital, London, United Kingdom, 9University of Birmingham, The School of Cancer Sciences, Birmingham, United Kingdom, 10Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Sheffield, United KingdomINTRODUCTION & OBJECTIVES: The POUT trial aims to establish whether platinum-based combination chemotherapy is superior to surveillance following nephro-ureterectomy with curative intent for upper tract transitional cell carcinoma (utTCC). POUT opened to recruitment in the UK on 31/05/2012, with the aim to randomise 345 participants world-wide over a 5-year period. The trial incorporates an initial 2 year recruitment optimisation phase, with qualitative research exploring issues relating to the recruitment process and targets relating to patient recruitment and the number of centres open. Initial milestones are: 9 centres open within 6 months of first centre opening, 18 centres open within first 12 months, and 22 patients recruited within the first 12 months.MATERIAL & METHODS: Previous trials of adjuvant chemotherapy for urothelial cancers suggest that potential challenges to recruitment include randomisation between “no treatment” vs chemotherapy with its potential toxicity, and early identification of eligible patients. To ensure trial design was pragmatic and consistent with current practice we conducted a survey of participating UK centres. Prior to regulatory submissions a dedicated patient focus group with those who had experience of utTCC met to ensure the trial was relevant to patients and to further develop patient documentation.RESULTS: 31 of 53 responding UK centres routinely place utTCC patients on surveillance following nephro-ureterectomy; 22 give chemotherapy if the patient is considered fit enough. The 13 respondents who specified chemotherapy regimens give gemcitabine and cisplatin or carboplatin, dependent on renal function. All centres discuss patients pre-operatively in a multi-disciplinary team meeting, but 7 centres do not routinely discuss patients post-operatively. The patient group welcomed the opportunity for utTCC patients to participate in research. They approved of the proposed randomisation between surveillance and chemotherapy and supported the use of a two stage pre- and 81 Peri-operative chemotherapy or surveillance in upper tract urothelial cancer (POUT - CRUK/11/027) - a randomised controlled trial to define standard post-operative managementEur Urol Suppl 2013;12;e81post-operative information giving process. Initial milestones relating to number of sites have been reached within 4 months of opening the trial and accrual is currently on target to meet the initial recruitment milestone.CONCLUSIONS: There is no consensus among UK clinicians regarding optimum post-operative treatment of muscle invasive utTCC. The POUT trial offers the opportunity to standardise post-operative management of utTCC internationally and is supported by urologists, oncologists and patient representatives from the target population. To optimise clinical impact and deliver overall target recruitment within timelines, international recruitment is planned. An initial POUT European collaborators meeting will be held at the 28th Annual EAU Congress, for further information contact POUT-icrctsu@icr.ac.uk.

English

A. Birtle

R. Lewis

J. Chester

J. Donovan

M. Johnson

R. Jones

R. Kockelbergh

T. Powles

R. Bryan

J. Catto

E. Jones

E. Hall

Crossref

81 Peri-operative chemotherapy or surveillance in upper tract urothelial cancer (POUT – CRUK/11/027) – a randomised controlled trial to define standard post-operative management

http://pure-oai.bham.ac.uk/ws/files/38197185/81_Peri_operative_chemotherapy_or_survei.pdf

Peri-operative chemotherapy or surveillance in upper tract urothelial cancer (POUT - CRUK/11/027) - a randomised controlled trial to define standard post-operative management

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