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POUT: A trial looking at chemotherapy after surgery for cancer of the upper urinary system

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What is the study about? 

POUT investigates treatment of cancer of the upper urinary system. POUT is looking at giving chemotherapy after surgery to remove the cancer.

The upper urinary system is made up of

  • The inner lining of both kidneys 
  • Both ureters, which connect the kidneys to the bladder

People with this type of cancer usually receive surgery to remove the kidney and ureter where the cancer is found, but do not receive further treatment. 

Bladder cancer is sensitive to chemotherapy and is similar to cancer of the upper urinary system. POUT investigates whether giving people the same type of chemotherapy used for bladder cancer will prevent their cancer from returning.

Results will be used to improve treatment for people with cancer of the upper urinary system in future.

 

Who is included in the study?

261 people with cancer of the upper urinary system joined POUT from 57 NHS hospitals.

What are the study treatments?

Everyone who joined POUT had already had surgery to remove their affected kidney and ureter. POUT included two groups:

  • Standard approach of close observation, with treatment if the cancer returned
  • Chemotherapy with gemcitabine plus either cisplatin or carboplatin 

Participants had regular check ups and we collected information about how they were getting on over five years.

Study results

Results were first published in 2020. Three years after joining the study:

  • 46 out of 100 people who had close observation were alive and free of cancer
  • 71 out of 100 people who had chemotherapy were alive and free of cancer 

The study showed that giving chemotherapy after surgery halves the risk of this type of cancer returning.

Updated results were published in 2024 after participants had been in the trial for at least five years. The 2024 results found that people who had chemotherapy were, on average, free of cancer for 18 months longer than those who had close observation. People who had chemotherapy also lived for an average of 11 months longer than those who had close observation.

Read a plain English summaries of the results:

2020 Results

2024 Results

A detailed summary of the results is also available on the Cancer Research UK website.

Primary Publication

Clinical trials

List of ICR-CTSU 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.

Find out more

Further information for participants 

Patient information sheet

Further information for healthcare professionals 

Protocol

Contact details and regulatory information

Chief Investigator: Prof Alison Birtle, Lancashire Teaching Hospitals NHS Foundation Trust

ICR-CTSU scientific lead: Prof Emma Hall

Trial management contact: [email protected]

Sponsor: The Institute of Cancer Research 

Funding: Cancer Research UK (CRUK/11/027)

Trial identifiers

EUDRACT number: 2011-002577-33

REC reference: 11/NW/0782

ISRCTN98387754

Publications and presentations

Birtle AJ, Jones R, Chester J, Lewis R, Biscombe K, Johnson M, Blacker A, Bryan RT, Catto JWF, Choudhury A, Das P, Jagdev S, Powles T, Wagstaff J, Cheung KC, Cafferty F, Hall E. Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial. Journal of Clinical Oncology.0(0):JCO.23.01659. DOI:10.1200/JCO.23.01659 

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;395(10232):1268–77. DOI: 10.1016/S0140-6736(20)30415-3

Lewis R, Todd R, Newton M, Jones RJ, Wilson C, Donovan JL, Bryan RT, Birtle A, Hall E; on behalf of the POUT Trial Management Group. The implementation and utility of patient screening logs in a multicentre randomised controlled oncology trial. Trials. 2020 Jul 8;21(1):629. DOI: 10.1186/s13063-020-04559-w

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. DOI: 10.1111/j.1464-410X.2012.11413.x

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.