A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer (POUT) (POUT)
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)
- 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
|Transitional Cell Carcinoma of Ureter||Drug: Chemotherapy Other: Surveillance||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer|
- Disease-free survival (DFS) [ Time Frame: 3 years ]To determine whether adjuvant combination chemotherapy improves the disease-free survival for patients with resected histologically confirmed muscle invasive (pT2-T4, N0-3) or node positive upper tract TCC.
- Overall survival [ Time Frame: Patients followed-up for 5 years ]Whether adjuvant platinum-based chemotherapy improves overall survival in this patient group
- Metastasis free survival [ Time Frame: Patients are followed up for 5 years ]To determine whether adjuvant platinum-based chemotherapy improves metastasis free survival in this patient group.
- Incidence of bladder second primary tumours [ Time Frame: Patients are followed up for 5 years ]Whether adjuvant platinum-based chemotherapy reduces incidence of second primary urothelial cancers
- Incidence of contralateral primary tumours [ Time Frame: Patients are followed up for 5 years ]To determine whether adjuvant platinum-based chemotherapy reduces incidence of contralateral primary urothelial cancers.
- Acute and late toxicity [ Time Frame: Patients are followed up for 5 years ]To assess the toxicity of chemotherapy in this patient group.
- Quality of life (QoL) [ Time Frame: Patients' QoL will be assessed over 2 years ]To assess the relative quality of life in patients undergoing adjuvant chemotherapy or surveillance in this patient group.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2022|
|Estimated Primary Completion Date:||May 2020 (Final data collection date for primary outcome measure)|
Patients allocated to surveillance will be seen at 4, 7, 10 and 13 weeks post randomisation - equivalent to the end of cycle in patients receiving chemotherapy - in order to collect details of early treatment failure in this group and comparative data relating to toxicity and quality of life. Patients on surveillance will then be followed up for signs of recurrence at the same intervals as those who received chemotherapy
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.
Patients allocated adjuvant chemotherapy will receive 4 x 21 day cycles of gemcitabine-cisplatin. Patients who have a sub-optimal renal function (GFR 30-49ml/min) will receive carboplatin instead of cisplatin.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01993979
|Contact: POUT Trial Manager||0208 722 firstname.lastname@example.org|
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|Principal Investigator:||Dr Alison Birtle||Lancashire Teaching Hospitals NHS Foundation Trust|