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23 May 2012
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| [ Print-friendly version ] |
| A Phase III randomised trial of PeriOperative chemotherapy versus sUrveillance in upper Tract urothelial cancer |
| ISRCTN | ISRCTN98387754 |
| ClinicalTrials.gov identifier | |
| Public title | A Phase III randomised trial of PeriOperative chemotherapy versus sUrveillance in upper Tract urothelial cancer |
| Scientific title | |
| Acronym | POUT |
| Serial number at source | 11494 |
| Study hypothesis |
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 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 |
| Lay summary | Not provided at time of registration |
| Ethics approval | 11/NE/0332 |
| Study design | Randomised; Interventional; Design type: Treatment |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Topic: National Cancer Research Network; Subtopic: Bladder Cancer, Renal Cancer; Disease: Urothelium |
| Participants - 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 |
| Participants - 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. |
| Anticipated start date | 01/03/2012 |
| Anticipated end date | 01/03/2017 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | Planned Sample Size: 345; UK Sample Size: 256 |
| Interventions |
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) |
| Primary outcome measure(s) | Disease free survival; Timepoint(s): The main time point of interest is three years after randomisation. |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Clinical Trials Awards and Advisory Committee (CTAAC) (UK) |
| Trial website | |
| Publications | |
| Contact name | Miss Emma Jones |
| Address | 15 Cotswold Road |
| City/town | Sutton |
| Zip/Postcode | SM2 5NG |
| Country | United Kingdom |
| POUT-icrctsu@icr.ac.uk | |
| Sponsor | Institute for Cancer Research (UK) |
| Address | Section of Clinical Trials, 15 Cotswold Road |
| City/town | Sutton |
| Zip/Postcode | SM2 5NG |
| Country | United Kingdom |
| Date applied | 31/01/2012 |
| Last edited | 31/01/2012 |
| Date ISRCTN assigned | 31/01/2012 |
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| © 2012 ISRCTN unless otherwise stated. | |
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