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POUT

A phase III randomised trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer.

Disease site: Bladder cancerurological 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.

Further information

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)

Further information including recruitment progress is available from the following link:

UK Clinical Trials Gateway

Patient friendly information is available from the following link:

CancerHelp UK

Publications and presentations

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.

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.

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