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

This study is currently recruiting participants.
Verified November 2013 by Institute of Cancer Research, United Kingdom
Sponsor:
ClinicalTrials.gov Identifier:
NCT01993979
First Posted: November 25, 2013
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom
  Purpose

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

Condition Intervention Phase
Transitional Cell Carcinoma of Ureter Drug: Chemotherapy Other: Surveillance Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Institute of Cancer Research, United Kingdom:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 345
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)
Arms Assigned Interventions
Surveillance
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
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.
Experimental: 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.
Drug: Chemotherapy
Other Names:
  • Gemcitabine
  • Cisplatin
  • Carboplatin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: POUT Trial Manager 0208 722 4288 pout-icrctsu@icr.ac.uk

  Show 61 Study Locations
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Cancer Research UK
Investigators
Principal Investigator: Dr Alison Birtle Lancashire Teaching Hospitals NHS Foundation Trust
  More Information

Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT01993979     History of Changes
Other Study ID Numbers: ICR-CTSU/2011/10031
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 Submitted: November 19, 2013
First Posted: November 25, 2013
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Institute of Cancer Research, United Kingdom:
Adjuvant chemotherapy
Surveillance
Nephro-ureterectomy

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Cisplatin
Carboplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs