A Phase III randomised trial of perioperative chemotherapy versus surveillance in upper tract urothelial cancer
| ISRCTN | ISRCTN98387754 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98387754 |
| ClinicalTrials.gov (NCT) | NCT01993979 |
| Clinical Trials Information System (CTIS) | 2011-002577-33 |
| Integrated Research Application System (IRAS) | 82914 |
| Protocol serial number | 11494, IRAS 82914 |
| Sponsor | Institute for Cancer Research (UK) |
| Funder | Clinical Trials Awards and Advisory Committee (CTAAC) (UK) |
- Submission date
- 31/01/2012
- Registration date
- 31/01/2012
- Last edited
- 27/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
| POUT-icrctsu@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A Phase III randomised trial of PeriOperative chemotherapy versus sUrveillance in upper Tract urothelial cancer |
| Study acronym | POUT |
| Study objectives | POUT is a Phase III multicentre randomised controlled trial. The objective is to determine the efficacy, safety and effects on patients' quality of life of adjuvant chemotherapy in patients who have undergone radical nephroureterectomy for upper urinary tract transitional cell carcinoma (TCC). |
| Ethics approval(s) | 11/NE/0332 |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Bladder Cancer, Renal Cancer; Disease: Urothelium |
| Intervention | Chemotherapy, Gemcitabine 1000 mg/m2 day 1 and day 8 as 30-minute intravenous infusion in 500ml sodium chloride; and Cisplatin 70 mg/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) Added 27/11/2025: Additional Data Linkage Information: Participants from this trial will also be included in the INTERACT project which will link to their data held by NHS England. For more information, please see the INTERACT website: https://www.icr.ac.uk/interact. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Gemcitabine, cisplatin, carboplatin |
| Primary outcome measure(s) |
Disease free survival; Timepoint(s): The main time point of interest is 3 years after randomisation. |
| Key secondary outcome measure(s) |
1. Acute toxicity; Timepoint(s): Whilst patients are on treatment and up to 3 months post-randomisation |
| Completion date | 21/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 345 |
| Total final enrolment | 261 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2012 |
| Date of final enrolment | 10/11/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Sutton
SM2 5NG
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from POUT-icrctsu@icr.ac.uk. Clinical data are available for sharing subject to completion of a data sharing application form, approval by the trial oversight committees and completion of a data sharing agreement. Each request will be reviewed to confirm whether the existing trial consent covers the application, what anonymisation will be required and whether separate ethics approval would be required. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/04/2020 | 10/03/2020 | Yes | No | |
| Results article | 13/02/2024 | 31/10/2025 | Yes | No | |
| Abstract results | 20/02/2018 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes | |||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/11/2025: The interventions were updated.
31/10/2025: The completion date was changed from 01/03/2017 to 21/10/2025. Study website, publication reference and IPD sharing plan added.
03/04/2020: Cancer Research UK lay results summary link added to Results (plain English).
11/03/2020: The following changes have been made:
1. The total final enrolment number has been changed from 248 to 261.
2. The IRAS number has been added.
10/03/2020: Publication reference added.
29/08/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
3. ClinicalTrials.gov number added.
22/01/2018: The recruitment end date was changed from 01/03/2017 to 10/11/2017.
