POUT

• Research type

  Research Study

• Full title

  A Phase III randomised trial of Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer

• IRAS ID

  82914

• Contact name

  Alison Birtle

• Sponsor organisation

  Institute of Cancer Research

• Eudract number

  2011-002577-33

• Research summary

  POUT is a randomised controlled trial which aims to establish the optimum management strategy following surgery to treat locally advanced upper urinary tract transitional cell carcinoma (TCC). This affects the cells which line the inside of the kidney (renal pelvis) and the ureter which connects the kidney to the bladder. This type of cancer is rare, with an estimated incidence of 2-4 cases per 100,000 individuals per year. Tumours frequently come back (recur) following surgery and survival rates are poor; for patients diagnosed in 2001-2003 five year survival was 50%. Current guidelines recommend surgery to remove the kidney and ureter (nephro-ureterectomy) and then close follow up (surveillance), with chemotherapy as needed if disease returns. Chemotherapy given around the time of surgery (peri-operative) has been found to be of benefit in patients with a similar cancer affecting the bladder, but although small studies have been conducted previously with promising results, there has never been a randomised controlled trial of peri-operative chemotherapy in upper tract TCC. In POUT, 345 participants who have received nephro-ureterectomy for locally advanced upper tract TCC will be randomised between the standard surveillance strategy and immediate chemotherapy. The main aim of POUT is to establish whether immediate chemotherapy extends the time after surgery that patients can expect to remain free of disease. In addition, the effect of chemotherapy on overall and metastases free survival time, the side effects it causes, how well participants adhere to their treatment regimen and the effect on participants' quality of life will also be examined. The study is funded by Cancer Research UK and will be conducted at NHS hospitals across the UK and in hospitals internationally.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  11/NW/0782

• Date of REC Opinion

  22 Dec 2011

• REC opinion

  Further Information Favourable Opinion