Overview

A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer (POUT)

Status:
Active, not recruiting

Trial end date:
2022-05-01

Target enrollment:

Participant gender:

Summary

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

Phase:

Phase 3

Details

Lead Sponsor:

Institute of Cancer Research, United Kingdom

Collaborator:

Cancer Research UK

Treatments:

Carboplatin
Cisplatin
Gemcitabine