POUT
Phase III randomised trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer.
Disease site: Urological cancers Bladder cancer
Treatment Modality:
Status: In follow-up
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.
POUT Trial results (plain English summary)
POUT Trial long term results (plain English summary)
A detailed summary of the results is also available on the Cancer Research UK website.
Further information for participants
Further information for healthcare professionals
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)
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.
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