A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus Surveillance in Upper Tract Urothelial Cancer


Condition: Transitional Cell Carcinoma of Ureter

Intervention:

  • Drug: Chemotherapy
  • Other: Surveillance

Purpose: 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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01993979

Sponsor: Institute of Cancer Research, United Kingdom

Primary Outcome Measures:

  • Measure: Disease-free survival (DFS)
  • Time Frame: 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival
  • Time Frame: Patients followed-up for 5 years
  • Safety Issue:
  • Measure: Metastasis free survival
  • Time Frame: Patients are followed up for 5 years
  • Safety Issue:
  • Measure: Incidence of bladder second primary tumours
  • Time Frame: Patients are followed up for 5 years
  • Safety Issue:
  • Measure: Incidence of contralateral primary tumours
  • Time Frame: Patients are followed up for 5 years
  • Safety Issue:
  • Measure: Acute and late toxicity
  • Time Frame: Patients are followed up for 5 years
  • Safety Issue:
  • Measure: Quality of life (QoL)
  • Time Frame: Patients' QoL will be assessed over 2 years
  • Safety Issue:

Estimated Enrollment: 345

Study Start Date: May 2012

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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
  • 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.

Contact:

  • POUT Trial Manager
  • 0208 722 4288

Locations:

  • William Harvey Hospital
  • Ashford-Kent England TN24 0LZ United Kingdom
  • North Devon District Hospital
  • Barnstaple England EX31 4JB United Kingdom
  • Basildon University Hospital
  • Basildon England SS16 5NL United Kingdom
  • Kent and Canterbury Hospital
  • Canterbury England CT2 3NG United Kingdom
  • Royal Free Hospital
  • Hampstead, London England NW3 2QG United Kingdom
  • Ipswich Hospital NHS Trust
  • Ipswich England IP4 5PD United Kingdom
  • St. James's University Hospital
  • Leeds England LS9 7TF United Kingdom
  • Barts and the London School of Medicine
  • London England EC1M 6BQ United Kingdom
  • Maidstone Hospital
  • Maidstone England ME16 9QQ United Kingdom
  • Christie Hospital NHS Trust
  • Manchester England M20 4BX United Kingdom
  • Queen Elizabeth The Queen Mother Hospital
  • Margate England CT9 4AN United Kingdom
  • Clatterbridge Centre for Oncology NHS Trust
  • Merseyside England CH63 4JY United Kingdom
  • Nottingham City Hospital NHS Trust
  • Nottingham England NG5 1PB United Kingdom
  • Peterborough Hospitals Trust
  • Peterborough England PE3 6DA United Kingdom
  • Rosemere Cancer Centre at Royal Preston Hospital
  • Preston England PR2 9HT United Kingdom
  • Cancer Research Centre at Weston Park Hospital
  • Sheffield England S1O 2SJ United Kingdom
  • Royal Marsden Hosital, Sutton
  • Surrey England SM2 5PT United Kingdom
  • Southend University Hospital NHS Foundation Trust
  • Westcliff-On-Sea England SS0 0RY United Kingdom
  • New Cross Hospital
  • Wolverhampton England WV10 0QP United Kingdom
  • Ayr Hospital
  • Ayr Scotland KA6 6DX United Kingdom
  • Velindre Cancer Center at Velinde Hospital
  • Cardiff Wales CF14 2TL United Kingdom
  • Singleton Hospital
  • Swansea Wales SA 2 8QA United Kingdom
  • Bristol Haematology and Oncology Centre
  • Bristol United Kingdom
  • Southmead Hospital
  • Bristol United Kingdom
  • Royal Marsden Hospital
  • Chelsea SW3 6JJ 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 EH4 2XU United Kingdom
  • Royal Devon and Exeter Hospital
  • Exeter United Kingdom
  • Beatson West of Scotland Cancer Centre
  • Glasgow United Kingdom
  • Royal Surrey County Hospital
  • Guildford GU2 7XX United Kingdom
  • Calderdale Royal Infirmary
  • Halifax United Kingdom
  • Huddersfield Royal Infirmary
  • Huddersfield United Kingdom
  • Caithness General Hospital
  • Inverness IV2 3UJ United Kingdom
  • Raigmore Hospital
  • Inverness IV2 3UJ United Kingdom
  • Leicester Royal Infirmary
  • Leicester United Kingdom
  • Lincoln County Hospital
  • Lincoln LN2 5QY United Kingdom
  • Royal Liverpool University Hospital
  • Liverpool L7 8XP United Kingdom
  • Guy's Hospital
  • London SE1 9RT United Kingdom
  • Charing Cross Hospital
  • London United Kingdom
  • Northwick Park Hospital
  • London United Kingdom
  • Manchester Royal Infirmary
  • Manchester M13 9WL United Kingdom
  • James Cook University Hospital
  • Middlesbrough United Kingdom
  • Freeman Hospital
  • Newcastle upon Tyne United Kingdom
  • Norfolk and Norwich University Hospital
  • Norwich NR4 7UY United Kingdom
  • Queen Alexandra Hospital,
  • Portsmouth United Kingdom
  • Glan Clywd Hospital
  • Rhyl LL18 5UJ United Kingdom
  • Queen's Hospital,
  • Romford, Essex United Kingdom
  • Royal Shrewsbury Hospital
  • Shrewsbury SY3 8XQ United Kingdom
  • Southampton General Hospital
  • Southampton United Kingdom
  • Lister Hospital
  • Stevenage SG1 4AA United Kingdom
  • University Hospital of North Tees
  • Stockton-on-Tees TS19 8PE United Kingdom
  • Frimley Park Hospital
  • Surrey GU16 7UJ United Kingdom
  • The Royal Marsden Hospital
  • Sutton SM2 5PT United Kingdom
  • Musgrove Park Hospital
  • Taunton United Kingdom
  • Torbay District General Hospital
  • Torbay TQ2 7AA United Kingdom
  • Royal Cornwall Hospital
  • Treliske TR1 3LJ United Kingdom
  • Worthing Hospital
  • Worthing BN11 2DH United Kingdom
  • York District Hospital
  • York YO31 8HE United Kingdom

View trial on ClinicalTrials.gov