887 - Peri-operative chemotherapy or surveillance in upper tract urothelial cancer (POUT - CRUK/11/027) - a new randomised controlled trial to define stan...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Cytotoxic agents
Urothelial Cancers
Biological therapy
Presenter Alison Birtle
Authors A.J. Birtle1, R. Lewis2, J. Chester3, J. Donovan4, M. Johnson5, R.J. Jones6, R. Kockelbergh7, T.B. Powles8, E. Jones9, E. Hall10
  • 1Rosemere Cancer Centre, Lancashire Teaching Hospitals NHS Foundation Trust, PR2 9HT - Preston/UK
  • 2Icr-ctsu, Institute of Cancer Research, SM2 5NG - Surrey/UK
  • 3Velindre Hospital, Cardiff University, Cardiff/UK
  • 4School Of Social And Community Medicine, University of Bristol, BS8 2PS - Bristol/UK
  • 5Freeman Hospital, Newcastle upon tyne hospitals NHS Trust, Newcastle/UK
  • 6Medical Oncology, Beatson West of Scotland Cancer Centre Gartnavel General Hospital, G12 0YN - Glasgow/UK
  • 7Department Of Urology, University Hospitals Leicester, Leicester/UK
  • 8Department Of Medical Oncology, St. Bartholomew's Hospital, EC1A 7BE - London/UK
  • 9Clincial Trials And Statistics Unit, Institute of Cancer Research, SM2 5NG - Surrey/UK
  • 10Clinical Trials And Statistics Unit, Institute of Cancer Research, SM2 5NG - Surrey/UK



The POUT trial aims to establish whether platinum-based combination chemotherapy is superior to surveillance following nephro-ureterectomy with curative intent for upper tract transitional cell carcinoma (utTCC).


We aim to randomise 345 participants world-wide, over a 5-year period. Previous trials of adjuvant chemotherapy for urothelial cancers suggest that potential challenges to recruitment include randomisation between “no treatment” vs chemotherapy with its potential toxicity, and early identification of eligible patients. To support trial design and the development of patient information, we therefore conducted a survey of participating UK centres' current standard treatment and also held a dedicated consumer focus group. During the trial set up period, additional sites expressed interest in participating and the survey was recirculated; results are presented here.


26 of 44 UK centres questioned routinely place utTCC patients on surveillance following surgery; 18 give chemotherapy if the patient is considered fit enough. The 9 respondents who specified chemotherapy regimens give gemcitabine and cisplatin or carboplatin, dependent on renal function. All centres discuss patients pre-operatively in a multi-disciplinary team meeting, but 6 centres do not routinely discuss patients post-operatively. The consumer group welcomed the opportunity for utTCC patients to participate in research. They approved of the proposed randomisation between surveillance and chemotherapy and supported the use of a two stage pre- and post-operative information giving process.


There is no consensus among UK clinicians regarding optimum post-operative treatment of muscle invasive utTCC. The POUT trial offers the opportunity to standardise post-operative management of utTCC internationally and is supported by urologists, oncologists and consumer representatives from the target patient population. The trial design incorporates an initial two-year recruitment optimisation phase which includes qualitative research to inform recruitment practices.


All authors have declared no conflicts of interest.