POUT
A phase III randomised trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer.
Disease site: Bladder cancer, urological cancers
Treatment modality: Systemic therapy
Status: In follow up
Trial details
POUT is a phase III, multicentre, randomised controlled trial to determine the efficacy, safety and effects on patients’ quality of life of adjuvant chemotherapy following radical nephro-ureterectomy for upper tract urothelial carcinoma, also known as upper urinary tract transitional cell carcinoma. POUT aims to define standard postoperative care for this patient group.
345 patients will be recruited from sites over 5 years. Participants will either receive immediate platinum based combination chemotherapy (gemcitabine–cisplatin or gemcitabine–carboplatin) or be allocated to the surveillance group to be closely monitored for signs of recurrence, receiving appropriate treatment if disease returns. Patients will be followed up annually.
Results
We have prepared a lay summary of the POUT results, which can be viewed and downloaded here.
Further information
Protocol
Main Patient Information Sheet
Surgery Patient Information Sheet
Chief Investigator: Dr Alison Birtle, Lancashire Teaching Hospitals NHS Foundation Trust
ICR-CTSU Scientific Lead: Dr Emma Hall
Trial management contact: [email protected]
ISRCTN: 98387754
Sponsor: The Institute of Cancer Research
Funding: Cancer Research UK (CRUK/11/027)
View POUT on the National Institute for Health Research website: NIHR - Be Part Of Research
Patient friendly information is available from the following link:
CancerHelp UK
Publications and presentations
Birtle A. Johnson M. Chester J. Jones R. Dolling D. Bryan R. Harris C. Winterbottom A. Blacker A. Catto J. Chakraborti P. Donovan J. Elliott P. French A. Jagdev S. Jenkins B. Keeley F. Kockelbergh R. Powles T. Wagstaff J. Wilson C. Todd R. Lewis R. Hall E. Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial. The Lancet 2020; Volume 395, Issue 10232, Pages 1268-1277
Birtle A. Johnson M. Kockelbergh R. Keeley F. Catto J. Bryan R. Chester J. Jones R. Hill M. Donovan J. French A. Harris C. Powles T. Todd R. Tregellas L. Wilson C. Winterbottom A. Lewis R. Hall E. Results of POUT - a phase III randomised trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer (UTUC). Presented at: European Association of Urology 2018, 16-20 March 2018 Copenhagen DK.
AJ. Birtle, JD Chester, RJ. Jones, M Johnson, M Hill, RT Bryan, J Catto, J Donovan, A French, C Harris, F Keeley, R Kockelbergh, T Powles, R Todd, L Tregellas, C Wilson, A Winterbottom, R Lewis, E Hall, on behalf of the POUT Investigators . Results of POUT: A phase III randomised trial of Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer (UTUC) Presented at: Genitourinary Cancers Symposium 2018 8-10 February; San Francisco, USA.
AJ Birtle, L Maynard, M Johnson, R Kockelbergh, R Jones, J Chester, J Catto, A Blacker, E Hall, on behalf of the POUT TMG. Acute toxicity data from POUT: a phase III randomised trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer. Presented at: British Association of Urological Nurses Annual Conference and exhibition; 2016 14-15 November; Liverpool, UK.
AJ Birtle, L Maynard, M Johnson, R Kockelbergh, R Jones, J Chester, J Catto, A Blacker, E Hall, on behalf of the POUT TMG. Acute toxicity data from POUT: a phase III randomised trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer. Presented at: British Association of Urological Surgeons Annual Scientific Meeting; 2016 27-29 June; Liverpool, UK.
Snape M, Lewis R, Wilson C, Jones E, Kockelbergh R, Jones R, Chester J, Hall E, Birtle A on behalf of the POUT TMG. The implementation and utility of screening logs in a randomised controlled trial of peri-operative chemotherapy or surveillance in upper tract urothelial cancer (POUT-CRUK/11/027). Presented at: The Society of Clinical Trials 36th Annual Meeting; 2015 May 17-20; Arlington, Virginia, USA.
Wilson C, Rooshenas L, Birtle A, Stein, R and Donovan JL on behalf the POUT TMG and OPTIMA TMG. The Uncertain Case for Adjuvant Chemotherapy: Lessons for Recruitment from Two Pragmatic Cancer Trials (Optima HTA10/34/01, POUT CRUK/11/027). Presented at: National Cancer Research Institute Cancer Conference; 2014 2-5 November; Liverpool, UK.
Wilson C, A B, Snape M, Lewis R, Hall E, Johnson M, Donovan J. Recruitment challenges for trials of rare cancers: Lessons from the POUT trial for transitional cell cancer of the urinary system CRUK/11/027. Presented at: National Cancer Research Institute Cancer Conference; 2014 2-5 November; Liverpool, UK.
Birtle A, Lewis R, Chester J, Donovan J, Johnson M, Jones R, Kockelbergh R, Powles T, Bryan R, Catto J, Jones E, Hall E; on behalf of the POUT Trial Management Group. Peri-operative chemotherapy or surveillance in upper tract urothelial cancer (POUT - CRUK/11/027) – a randomised controlled trial to define standard post-operative management. Presented at: 28th Annual European Association of Urology Congress; 2013 March 15-19; Milan, Italy.
Birtle AJ, Lewis R, Johnson M, Hall E; on behalf of the POUT Trial Management Group. Time to define an international standard of postoperative care for resected upper urinary tract transitional cell carcinoma (TCC) – opening of the peri-operative chemotherapy versus surveillance in upper tract urothelial cancer (POUT) trial. BJU Int. 2012; 110(7): 919-21.
Birtle A, Lewis R, Chester J, Donovan J, Johnson M, Jones R, Kockelbergh R, Powles T, Jones E, Hall E. Peri-operative chemotherapy or surveillance in upper tract urothelial cancer (POUT CRUK/11/027) – a new randomised controlled trial to define standard post-operative management. Presented at: 9th National Cancer Research Institute Cancer Conference; 2012 Nov 3-6; Liverpool, UK; A58.
Birtle A, Lewis R, Chester J, Donovan J, Johnson M, Jones RJ, Kockelbergh R, Powles TB, Jones E, Hall E. Peri-operative chemotherapy or surveillance in upper tract urothelial cancer (POUT - CRUK/11/027) – a new randomised controlled trial to define standard post-operative management. Ann Oncol. 2012; 23(Suppl 9): ix292 #887.
Birtle A. Call for investigators to define international standard of care. POUT: a phase III randomised trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer - CR-UK/11/027. European Urology Today 2012; 24(2): 27.
Birtle A, Lewis R, Chester J, Donovan J, Johnson M, Jones R, Keeley F, Kockelbergh R, Powles T, Hall E. Peri-operative chemotherapy of surveillance in upper tract urothelial cancer (POUT CRUK/11/027): a new randomised controlled trial to define standard post-operative management. Presented at: British Association of Urological Surgeons Meeting, Section of Oncology; Nov 2011; London, UK.