A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveill... | Recruiting
A Phase III Randomised Trial of Per... | Recruiting
A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer (POUT)
POUT

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Medical Conditions
  • Transitional Cell Carcinoma of Ureter
Primary Contact Details
POUT Trial Manager
0208 722 4288
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01993979
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Chemotherapy, Other : Surveillance

Study Arm Groups : Chemotherapy, Surveillance

Intervention Type
See Interventions above
Primary Outcome Measures
    Disease-free survival (DFS); 3 years
Secondary Outcome Measures
    Overall survival; Patients followed-up for 5 years; Metastasis free survival; Patients are followed up for 5 years; Incidence of bladder second primary tumours; Patients are followed up for 5 years; Incidence of contralateral primary tumours; Patients are followed up for 5 years; Acute and late toxicity; Patients are followed up for 5 years; Quality of life (QoL); Patients' QoL will be assessed over 2 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
345
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Local Institution
Glasgow
Central
Local Institution
London
Greater London
Oxford Road
Manchester
M13 9WL
Maidstone Hospital
Maidstone
England
ME16 9QQ
Rosemere Cancer Centre at Royal Preston Hospital
Fulwood
England
PR2 9HT
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
Velindre Cancer Center at Velindre Hospital
Cardiff
Wales
CF14 2TL
Ipswich Hospital NHS Trust - Department of Clinical Neurology
Ipswich
IP4 5PD
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Guy's Hospital
London
SE1 9RT
Nottingham
Nottinghamshire
NG5 1PB
Novartis Investigative Site
Wolverhampton
WV10 0QP
Newcastle upon Tyne
Guildford
GU2 7XX
Norwich
NR4 7UY
Worthing
BN11 2DH
York
YO31 8HE
Liverpool
Merseyside
L7 8XP
Inverness
IV2 3UJ
Basildon University Hospital
Basildon
England
SS16 5NL
Lincoln County Hospital
Lincoln
England
LN2 5QY
Cancer Research Centre at Weston Park Hospital
England
S1O 2SJ
Clatterbridge Centre for Oncology NHS Trust
Birkenhead
England
CH63 4JY
Southend NHS Trust Hospital
Southend-on-Sea
England
SS0 0RY
Sutton
SM2 5PT
Brook Lane Surgery
Southampton
Stockton-on-Tees
TS19 8PE
Huddersfield
Uni Hospital Leicester
Leicester
Derby
Queen Alexandra Hospital
Portsmouth
Bristol
London
EC1M 6BQ
University Hospital
Coventry
Exeter
Taunton
Darent Valley Hospital
Dartford
The James Cook University Hospital
Middlesbrough
Royal Free Hospital
London
England
NW3 2QG
Peterborough Hospitals Trust
Peterborough
England
PE3 6DA
Site Reference ID/Investigator# 125689
Barnstaple
EX31 4JB
William Harvey Hospital
Willesborough
England
TN24 0LZ
Queen Elizabeth The Queen Mother Hospital
Margate
England
CT9 4AN
Royal Shrewsbury Hospital
Shrewsbury
England
SY3 8XQ
Royal Bournemouth Hospital
Dorset
Novartis Investigative Site
Rhyl
LL18 5UJ
Singleton Hospital
Sketty
SA 2 8QA
Frimley Park Hospital
Frimley
GU16 7UJ
Kent and Canterbury Hospital
Canterbury
England
CT2 3NG
Ayr Hospital
Ayr
Scotland
KA6 6DX
Royal Marsden Hospital
London
SW3 6JJ
Calderdale Royal Infirmary
Halifax
Queen's Hospital,
Romford
Lister Hospital
Stevenage
SG1 4AA
Torbay District General Hospital
Torquay
TQ2 7AA
Royal Cornwall Hospital
Truro
TR1 3LJ
Trial Contact(s)
Primary Trial Contact
POUT Trial Manager
0208 722 4288
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer
EudraCT Number
Not available for this trial
Funder(s)
  • Cancer Research UK
Other Study ID Numbers
ICR-CTSU/2011/10031
Sponsor(s)
Institute of Cancer Research, United Kingdom
Key Dates

Recruitment Start Date

May 2012

Recruitment End Date

May 2020

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

19 Nov 2013

Date updated in source

19 Nov 2013