A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer (POUT)
Conditions
Transitional Cell Carcinoma of Ureter
Conditions: official terms
Carcinoma, Transitional Cell - Ureteral Neoplasms
Conditions: Keywords
Adjuvant chemotherapy, Surveillance, Nephro-ureterectomy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Chemotherapy Type: Drug
Name: Surveillance Type: Other
Overall Status
Recruiting
Summary
POUT is a multi-centred randomised controlled phase III trial. 345 patients who have undergone nephro-ureterectomy, are surgically staged pT2-pT4, N0-3 or are pT1 and node positive, and who are fit for adjuvant chemotherapy, will be randomised to four cycles of adjuvant platinum based chemotherapy (experimental group) or surveillance (control group). Participants will be followed up according to routine practice.

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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Written informed consent

- ≥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:

- Evidence of distant metastases

- 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.
Locations
William Harvey Hospital
Ashford-Kent, England, United Kingdom
Status: Recruiting
North Devon District Hospital
Barnstaple, England, United Kingdom
Status: Recruiting
Basildon University Hospital
Basildon, England, United Kingdom
Status: Recruiting
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Status: Recruiting
Royal Free Hospital
Hampstead, London, England, United Kingdom
Status: Recruiting
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom
Status: Recruiting
St. James's University Hospital
Leeds, England, United Kingdom
Status: Recruiting
Contact: - 44-113-392-4307
Barts and the London School of Medicine
London, England, United Kingdom
Status: Recruiting
Maidstone Hospital
Maidstone, England, United Kingdom
Status: Recruiting
Christie Hospital NHS Trust
Manchester, England, United Kingdom
Status: Recruiting
Contact: - 44-845-226-3000
Queen Elizabeth The Queen Mother Hospital
Margate, England, United Kingdom
Status: Recruiting
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-151-334-1155
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Status: Recruiting
Peterborough Hospitals Trust
Peterborough, England, United Kingdom
Status: Recruiting
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom
Status: Recruiting
Contact: Alison Birtle, MD - alison.birtle@lthtr.nhs.uk
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Status: Recruiting
Royal Marsden Hosital, Sutton
Surrey, England, United Kingdom
Status: Recruiting
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England, United Kingdom
Status: Recruiting
New Cross Hospital
Wolverhampton, England, United Kingdom
Status: Recruiting
Ayr Hospital
Ayr, Scotland, United Kingdom
Status: Recruiting
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, United Kingdom
Status: Recruiting
Singleton Hospital
Swansea, Wales, United Kingdom
Status: Recruiting
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
Status: Recruiting
Southmead Hospital
Bristol, United Kingdom
Status: Recruiting
Royal Marsden Hospital
Chelsea, United Kingdom
Status: Recruiting
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
Status: Recruiting
Darent Valley Hospital
Dartford, United Kingdom
Status: Recruiting
Royal Derby Hospital
Derby, United Kingdom
Status: Recruiting
Royal Bournemouth General Hospital
Dorset, United Kingdom
Status: Recruiting
Western General Hospital
Edinburgh, United Kingdom
Status: Recruiting
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Status: Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Status: Recruiting
Royal Surrey County Hospital
Guildford, United Kingdom
Status: Recruiting
Calderdale Royal Infirmary
Halifax, United Kingdom
Status: Recruiting
Huddersfield Royal Infirmary
Huddersfield, United Kingdom
Status: Recruiting
Caithness General Hospital
Inverness, United Kingdom
Status: Recruiting
Raigmore Hospital
Inverness, United Kingdom
Status: Recruiting
Contact: Neil McPhail - 01463 704197
Leicester Royal Infirmary
Leicester, United Kingdom
Status: Recruiting
Lincoln County Hospital
Lincoln, United Kingdom
Status: Recruiting
Royal Liverpool University Hospital
Liverpool, United Kingdom
Status: Recruiting
Charing Cross Hospital
London, United Kingdom
Status: Recruiting
Guy's Hospital
London, United Kingdom
Status: Recruiting
Northwick Park Hospital
London, United Kingdom
Status: Recruiting
Manchester Royal Infirmary
Manchester, United Kingdom
Status: Recruiting
James Cook University Hospital
Middlesbrough, United Kingdom
Status: Recruiting
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Status: Recruiting
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Status: Recruiting
Queen Alexandra Hospital,
Portsmouth, United Kingdom
Status: Recruiting
Glan Clywd Hospital
Rhyl, United Kingdom
Status: Recruiting
Queen's Hospital,
Romford, Essex, United Kingdom
Status: Recruiting
Royal Shrewsbury Hospital
Shrewsbury, United Kingdom
Status: Recruiting
Southampton General Hospital
Southampton, United Kingdom
Status: Recruiting
Lister Hospital
Stevenage, United Kingdom
Status: Recruiting
University Hospital of North Tees
Stockton-on-Tees, United Kingdom
Status: Recruiting
Frimley Park Hospital
Surrey, United Kingdom
Status: Recruiting
The Royal Marsden Hospital
Sutton, United Kingdom
Status: Recruiting
Contact: Robert Huddart - 020 8661 3457
Musgrove Park Hospital
Taunton, United Kingdom
Status: Recruiting
Torbay District General Hospital
Torbay, United Kingdom
Status: Recruiting
Royal Cornwall Hospital
Treliske, United Kingdom
Status: Recruiting
Worthing Hospital
Worthing, United Kingdom
Status: Recruiting
York District Hospital
York, United Kingdom
Status: Recruiting
Start Date
May 2012
Completion Date
May 2022
Sponsors
Institute of Cancer Research, United Kingdom
Source
Institute of Cancer Research, United Kingdom
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page