Condition category
Cancer
Date applied
31/01/2012
Date assigned
31/01/2012
Last edited
19/07/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Miss Emma Jones

ORCID ID

Contact details

15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
POUT-icrctsu@icr.ac.uk

Additional identifiers

EudraCT number

2011-002577-33

ClinicalTrials.gov number

Protocol/serial number

11494

Study information

Scientific title

Acronym

POUT

Study hypothesis

POUT is a phase III multicentre randomised controlled trial. The objective is to determine the efficacy, safety and effects on patientsÂ’ quality of life of adjuvant chemotherapy in patients who have undergone radical nephro-ureterectomy for upper urinary tract transitional cell carcinoma (TCC).

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11494

Ethics approval

11/NE/0332

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Bladder Cancer, Renal Cancer; Disease: Urothelium

Intervention

Chemotherapy, Gemcitabine 1000mg/m2 day 1 and day 8 as 30 minute intravenous infusion in 500ml sodium chloride; and

Cisplatin 70mg/m2 day 1 as a 4 hour intravenous infusion or (for participants with a creatinine clearance of 25-49ml only) Carboplatin AUC 4.5 or AUC 5 (according to local practice)

Carboplatin will be given to patients who are fit for chemotherapy and fulfil all trial entry criteria but have GFR 30-49 ml/min.

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. Patients on surveillance will then be followed up for signs of recurrence at the same intervals as those who received chemotherapy.; Follow Up Length: 60 month(s)

Intervention type

Drug

Phase

Phase III

Drug names

Gemcitabine, cisplatin, carboplatin

Primary outcome measures

Disease free survival; Timepoint(s): The main time point of interest is three years after randomisation.

Secondary outcome measures

1. Acute toxicity; Timepoint(s): Whilst patients are on treatment and up to 3 months post-randomisation
2. Contralateral second primary utTCC; Timepoint(s): The primary timepoint of interest is 3 years
3. Invasive recurrence/second primary in the bladder; Timepoint(s): The primary timepoint of interest is 3 years after randomisation
4. Late toxicity; Timepoint(s): 6 months, 2 years
5. Metastasis free survival; Timepoint(s): The primary timepoint of interest is 3 years.
6. Overall survival; Timepoint(s): The primary timepoint of interest is 3 years after randomisation
7. Quality of life (QoL) as measured by the EORTC QLQ-C30 and EQ5D modules.; Timepoint(s): We are collecting information on QoL up to 2 years post randomisation
8. Treatment compliance (in the chemotherapy arm); Timepoint(s): Once chemotherapy has been completed; Trial feasibility; Timepoint(s): Defined by recruitment over the first two years

Overall trial start date

01/03/2012

Overall trial end date

01/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent
2. >or =18 years of age
3. Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component - squamoid differentiation or mixed TCC/ small cell carcinoma (SCC) is permitted
4. 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)
5. Satisfactory haematological profile (ANC> 1.5 x 109/L, platelet count 100 x 10/L) and liver function tests (bilirubin < 1.5 x ULN, AST and Alkaline phosphatase < 2.5 x ULN), Glomerular filtration rate = 30 mls/min
6. Fit and willing to receive adjuvant chemotherapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated
7. WHO performance status 0-1.
8. Available for long-term follow-up; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 345; UK Sample Size: 256

Participant exclusion criteria

1. Evidence of distant metastases
2. Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology
3. Un-resected macroscopic nodal disease
4. Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)
5. Glomerular filtration rate (GFR) <30 ml/minute. Gemcitabine-carboplatin can only be given for patients with suboptimal renal function for cisplatin ie 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
6. Significant co-morbid conditions that would interfere with administration of protocol treatment
7. 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)
8. Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, carcinoma in situ (CIS) of cervix or Lobular carcinoma in situ (LCIS) of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.

Recruitment start date

01/03/2012

Recruitment end date

01/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Sponsor information

Organisation

Institute for Cancer Research (UK)

Sponsor details

Section of Clinical Trials
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Sponsor type

Research organisation

Website

http://www.icr.ac.uk/

Funders

Funder type

Government

Funder name

Clinical Trials Awards and Advisory Committee (CTAAC) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes