A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer (POUT) (POUT)
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|ClinicalTrials.gov Identifier: NCT01993979|
Recruitment Status : Unknown
Verified April 2020 by Institute of Cancer Research, United Kingdom.
Recruitment status was: Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : May 4, 2020
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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
|Condition or disease||Intervention/treatment||Phase|
|Transitional Cell Carcinoma of Ureter||Drug: Chemotherapy Other: Surveillance||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||261 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||November 7, 2018|
|Estimated Study Completion Date :||May 2022|
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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Written informed consent
- ≥18 years of age
- Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component - squamoid differentiation or mixed TCC/SCC is permitted.
- Histologically confirmed TCC staged pT2-pT4 pN0-3 M0 or pTany N1-3 M0 (providing all grossly abnormal nodes are resected). Patients with microscopically positive margins on pathology may be entered (providing all grossly abnormal disease was resected).
- Satisfactory haematological profile (ANC> 1.5 x 109/L, platelet count ≥ 100 x 109/L) and liver function tests (bilirubin < 1.5 x ULN, AST and Alkaline phosphatase < 2.5 x ULN), Glomerular filtration rate ≥30 mls/min.
- Fit and willing to receive adjuvant chemotherapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated
- WHO performance status 0-1.
- Available for long-term follow-up
- Evidence of distant metastases
- Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology
- Un-resected macroscopic nodal disease
- Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)
- GFR <30 ml/minute. NB Gemcitabine-carboplatin can only be given for patients with suboptimal renal function for cisplatin i.e. for GFR 30-49ml/min. Patients with poor performance status or co-morbidities that would make them unfit for chemotherapy are ineligible for the trial
- Significant co-morbid conditions that would interfere with administration of protocol treatment
- Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active);
- Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993979
|Principal Investigator:||Dr Alison Birtle||Lancashire Teaching Hospitals NHS Foundation Trust|
|Responsible Party:||Institute of Cancer Research, United Kingdom|
|Other Study ID Numbers:||
2011-002577-33 ( EudraCT Number )
ISRCTN98387754 ( Registry Identifier: ISRCTN )
CRUK/11/027 ( Other Grant/Funding Number: Cancer Research UK (CR UK) )
11/NW/0782 ( Other Identifier: Main REC )
|First Posted:||November 25, 2013 Key Record Dates|
|Last Update Posted:||May 4, 2020|
|Last Verified:||April 2020|
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action