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Transitional Cell Carcinoma of UreterPhase 3POUTNCT01993979

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

A Phase 3 study testing Chemotherapy and Surveillance in people with Transitional Cell Carcinoma of Ureter, run by Institute of Cancer Research, United Kingdom at 61 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transitional Cell Carcinoma of Ureter
What is being tested?
Chemotherapy and Surveillance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
261 participants
Where
61 sitesUnited Kingdom
Study dates
May 2012to May 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

United Kingdom61 sites

  • William Harvey Hospital

    Ashford-Kent, England, TN24 0LZ

  • Ayr Hospital

    Ayr, Scotland, KA6 6DX

  • North Devon District Hospital

    Barnstaple, England, EX31 4JB

  • Basildon University Hospital

    Basildon, England, SS16 5NL

  • Bristol Haematology and Oncology Centre

    Bristol

  • Southmead Hospital

    Bristol

  • Kent and Canterbury Hospital

    Canterbury, England, CT2 3NG

  • Velindre Cancer Center at Velinde Hospital

    Cardiff, Wales, CF14 2TL

  • Royal Marsden Hospital

    Chelsea, SW3 6JJ

  • University Hospitals Coventry and Warwickshire NHS Trust

    Coventry

  • Darent Valley Hospital

    Dartford

  • Royal Derby Hospital

    Derby

  • Royal Bournemouth General Hospital

    Dorset

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Royal Devon and Exeter Hospital

    Exeter

  • Beatson West of Scotland Cancer Centre

    Glasgow

  • Royal Surrey County Hospital

    Guildford, GU2 7XX

  • Calderdale Royal Infirmary

    Halifax

  • Royal Free Hospital

    Hampstead, London, England, NW3 2QG

  • Huddersfield Royal Infirmary

    Huddersfield

  • Caithness General Hospital

    Inverness, IV2 3UJ

  • Raigmore Hospital

    Inverness, IV2 3UJ

  • Ipswich Hospital NHS Trust

    Ipswich, England, IP4 5PD

  • St. James's University Hospital

    Leeds, England, LS9 7TF

  • Leicester Royal Infirmary

    Leicester

  • Lincoln County Hospital

    Lincoln, LN2 5QY

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Barts and the London School of Medicine

    London, England, EC1M 6BQ

  • Guy's Hospital

    London, SE1 9RT

  • Charing Cross Hospital

    London

  • Northwick Park Hospital

    London

  • Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Christie Hospital NHS Trust

    Manchester, England, M20 4BX

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • Queen Elizabeth The Queen Mother Hospital

    Margate, England, CT9 4AN

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, CH63 4JY

  • James Cook University Hospital

    Middlesbrough

  • Freeman Hospital

    Newcastle upon Tyne

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Peterborough Hospitals Trust

    Peterborough, England, PE3 6DA

  • Queen Alexandra Hospital,

    Portsmouth

  • Rosemere Cancer Centre at Royal Preston Hospital

    Preston, England, PR2 9HT

  • Glan Clywd Hospital

    Rhyl, LL18 5UJ

  • Queen's Hospital,

    Romford, Essex

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Royal Shrewsbury Hospital

    Shrewsbury, SY3 8XQ

  • Southampton General Hospital

    Southampton

  • Lister Hospital

    Stevenage, SG1 4AA

  • University Hospital of North Tees

    Stockton-on-Tees, TS19 8PE

  • Royal Marsden Hosital, Sutton

    Surrey, England, SM2 5PT

  • Frimley Park Hospital

    Surrey, GU16 7UJ

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

  • Singleton Hospital

    Swansea, Wales, SA 2 8QA

  • Musgrove Park Hospital

    Taunton

  • Torbay District General Hospital

    Torbay, TQ2 7AA

  • Royal Cornwall Hospital

    Treliske, TR1 3LJ

  • Southend University Hospital NHS Foundation Trust

    Westcliff-on-Sea, England, SS0 0RY

  • New Cross Hospital

    Wolverhampton, England, WV10 0QP

  • Worthing Hospital

    Worthing, BN11 2DH

  • York District Hospital

    York, YO31 8HE

Other trials in United Kingdom

About this study

Official title: A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer

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
Being tested
Chemotherapy, Surveillance
Keywords
Adjuvant chemotherapy, Surveillance, Nephro-ureterectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChemotherapyDrug

    Also called Gemcitabine, Cisplatin, Carboplatin

  • SurveillanceOther

    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.

Study groups in NCT01993979
Study groupRoleWhat they receive
SurveillanceOtherPatients 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
Receives: Other: Surveillance
ChemotherapyExperimentalPatients 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.
Receives: Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival (DFS)

    To determine whether adjuvant combination chemotherapy improves the disease-free survival for patients with resected histologically confirmed muscle invasive (pT2-T4, N0-3) or node positive upper tract TCC.

    Measured: 3 years

Secondary outcomes (6)

  1. Overall survival

    Whether adjuvant platinum-based chemotherapy improves overall survival in this patient group

    Measured: Patients followed-up for 5 years

  2. Metastasis free survival

    To determine whether adjuvant platinum-based chemotherapy improves metastasis free survival in this patient group.

    Measured: Patients are followed up for 5 years

  3. Incidence of bladder second primary tumours

    Whether adjuvant platinum-based chemotherapy reduces incidence of second primary urothelial cancers

    Measured: Patients are followed up for 5 years

  4. Incidence of contralateral primary tumours

    To determine whether adjuvant platinum-based chemotherapy reduces incidence of contralateral primary urothelial cancers.

    Measured: Patients are followed up for 5 years

  5. Acute and late toxicity

    To assess the toxicity of chemotherapy in this patient group.

    Measured: Patients are followed up for 5 years

  6. Quality of life (QoL)

    To assess the relative quality of life in patients undergoing adjuvant chemotherapy or surveillance in this patient group.

    Measured: Patients' QoL will be assessed over 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2013 (estimated)
  2. Study startMay 2012
  3. Primary completion7 Nov 2018
  4. Study completionMay 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01993979
Sponsor's protocol ID
ICR-CTSU/2011/10031
Other IDs
2011-002577-33, ISRCTN98387754, CRUK/11/027, 11/NW/0782
Acronym
POUT
Status last verified
Apr 2020
First submitted
19 Nov 2013
Last updated
4 May 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32145825

  • 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.

    PubMed 38350047

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chemotherapy and Surveillance in people with Transitional Cell Carcinoma of Ureter, run by Institute of Cancer Research, United Kingdom at 61 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01993979, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.

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