A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer (POUT)
NCT ID: NCT01993979
Last Updated: 2020-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
261 participants
INTERVENTIONAL
2012-05-31
2022-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Primary endpoint: Disease-free survival (DFS)
Secondary endpoints:
* Overall Survival
* Metastasis free survival
* Incidence of bladder second primary tumours
* Incidence of contralateral primary tumours
* Acute and late toxicity
* Treatment compliance
* Quality of life
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neoadjuvant Chemotherapy in Upper Tract Urothelial Carcinoma : a Retrospective Multicentric Study.
NCT05671042
Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)
NCT04574960
Efficacy Study of Adding Chemotherapy to Radiotherapy for Treating Bladder Cancer.
NCT00330499
Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer
NCT01776138
A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract
NCT05868265
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Surveillance
Patients allocated to surveillance will be seen at 4, 7, 10 and 13 weeks post randomisation - equivalent to the end of cycle in patients receiving chemotherapy - in order to collect details of early treatment failure in this group and comparative data relating to toxicity and quality of life. Patients on surveillance will then be followed up for signs of recurrence at the same intervals as those who received chemotherapy
Surveillance
Patients will be closely monitored for early signs of recurrence, for which they will receive treatment as decided in discussion between the clinician and patient. This may include chemotherapy.
Chemotherapy
Patients allocated adjuvant chemotherapy will receive 4 x 21 day cycles of gemcitabine-cisplatin. Patients who have a sub-optimal renal function (GFR 30-49ml/min) will receive carboplatin instead of cisplatin.
Chemotherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Chemotherapy
Surveillance
Patients will be closely monitored for early signs of recurrence, for which they will receive treatment as decided in discussion between the clinician and patient. This may include chemotherapy.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ≥18 years of age
* Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component - squamoid differentiation or mixed TCC/SCC is permitted.
* Histologically confirmed TCC staged pT2-pT4 pN0-3 M0 or pTany N1-3 M0 (providing all grossly abnormal nodes are resected). Patients with microscopically positive margins on pathology may be entered (providing all grossly abnormal disease was resected).
* Satisfactory haematological profile (ANC\> 1.5 x 109/L, platelet count ≥ 100 x 109/L) and liver function tests (bilirubin \< 1.5 x ULN, AST and Alkaline phosphatase \< 2.5 x ULN), Glomerular filtration rate ≥30 mls/min.
* Fit and willing to receive adjuvant chemotherapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated
* WHO performance status 0-1.
* Available for long-term follow-up
Exclusion Criteria
* Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology
* Un-resected macroscopic nodal disease
* Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)
* GFR \<30 ml/minute. NB Gemcitabine-carboplatin can only be given for patients with suboptimal renal function for cisplatin i.e. for GFR 30-49ml/min. Patients with poor performance status or co-morbidities that would make them unfit for chemotherapy are ineligible for the trial
* Significant co-morbid conditions that would interfere with administration of protocol treatment
* Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active);
* Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cancer Research UK
OTHER
Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr Alison Birtle
Role: PRINCIPAL_INVESTIGATOR
Lancashire Teaching Hospitals NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
William Harvey Hospital
Ashford-Kent, England, United Kingdom
North Devon District Hospital
Barnstaple, England, United Kingdom
Basildon University Hospital
Basildon, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Royal Free Hospital
Hampstead, London, England, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom
St. James's University Hospital
Leeds, England, United Kingdom
Barts and the London School of Medicine
London, England, United Kingdom
Maidstone Hospital
Maidstone, England, United Kingdom
Christie Hospital NHS Trust
Manchester, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Margate, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Peterborough Hospitals Trust
Peterborough, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Royal Marsden Hosital, Sutton
Surrey, England, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Ayr Hospital
Ayr, Scotland, United Kingdom
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, United Kingdom
Singleton Hospital
Swansea, Wales, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Royal Marsden Hospital
Chelsea, , United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, , United Kingdom
Darent Valley Hospital
Dartford, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Royal Bournemouth General Hospital
Dorset, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
Calderdale Royal Infirmary
Halifax, , United Kingdom
Huddersfield Royal Infirmary
Huddersfield, , United Kingdom
Caithness General Hospital
Inverness, , United Kingdom
Raigmore Hospital
Inverness, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Lincoln County Hospital
Lincoln, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Guy's Hospital
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Northwick Park Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Queen Alexandra Hospital,
Portsmouth, , United Kingdom
Glan Clywd Hospital
Rhyl, , United Kingdom
Queen's Hospital,
Romford, Essex, , United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Lister Hospital
Stevenage, , United Kingdom
University Hospital of North Tees
Stockton-on-Tees, , United Kingdom
Frimley Park Hospital
Surrey, , United Kingdom
The Royal Marsden Hospital
Sutton, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Torbay District General Hospital
Torbay, , United Kingdom
Royal Cornwall Hospital
Treliske, , United Kingdom
Worthing Hospital
Worthing, , United Kingdom
York District Hospital
York, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Birtle A, Johnson M, Chester J, Jones R, Dolling D, Bryan RT, Harris C, Winterbottom A, Blacker A, Catto JWF, Chakraborti P, Donovan JL, Elliott PA, French A, Jagdev S, Jenkins B, Keeley FX Jr, 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. Lancet. 2020 Apr 18;395(10232):1268-1277. doi: 10.1016/S0140-6736(20)30415-3. Epub 2020 Mar 5.
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. J Clin Oncol. 2024 May 1;42(13):1466-1471. doi: 10.1200/JCO.23.01659. Epub 2024 Feb 13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-002577-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISRCTN98387754
Identifier Type: REGISTRY
Identifier Source: secondary_id
CRUK/11/027
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
11/NW/0782
Identifier Type: OTHER
Identifier Source: secondary_id
ICR-CTSU/2011/10031
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.