Transitional Cell Carcinoma of Ureter Clinical Trial
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
n/a