NCT01993979

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Institute of Cancer Research, United Kingdom · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Transitional Cell Carcinoma of Ureter

Interventions

Type	Name	Description
DRUG	Chemotherapy
OTHER	Surveillance	Patients will be closely monitored for early signs of recurrence, for which they will receive treatment as decided in discussion between the clinician and patient. This may include chemotherapy.

Timeline

• Start date: 2012-05-01
• Primary completion: 2018-11-07
• Completion: 2022-05-01
• First posted: 2013-11-25
• Last updated: 2020-05-04

Locations

61 sites across 1 country: United Kingdom