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Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging (PET MUSE)

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ClinicalTrials.gov Identifier: NCT02462239
Recruitment Status : Recruiting
First Posted : June 4, 2015
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Cancer Care Ontario
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Tracking Information
First Submitted Date  ICMJE May 27, 2015
First Posted Date  ICMJE June 4, 2015
Last Update Posted Date April 5, 2018
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
Treatment received [ Time Frame: 5 years ]
For patients with planned cystectomy, treatment received includes: avoidance of planned cystectomy and node dissection, an extended (vs standard) node dissection (or standard dissection when extended is the surgeon's usual practice), use of neoadjuvant chemotherapy (vs no neoadjuvant chemotherapy). For patients with planned bladder conservation, treatment received includes: avoidance of bladder and nodal radiation (vs bladder only or no radiation) and use of neoadjuvant chemotherapy (or not).
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
Treatment received [ Time Frame: 5 years ]
Treatment received including: avoidance of cystectomy, more extensive lymph node dissection, or neoadjuvant chemotherapy followed by cystectomy.
Change History Complete list of historical versions of study NCT02462239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
  • Disease-free survival [ Time Frame: 5 years ]
    Disease-free survival defined as objectively defined (RECIST criteria, version 1.1.) local or distant recurrence or death.
  • Overall survival [ Time Frame: 5 years ]
    Overall survival defined by all-cause mortality.
  • Quality of life analysis [ Time Frame: 5 years ]
    Overall QOL assessed using the EORTC QLQ-C30 version 3.
  • Health economic analysis [ Time Frame: 5 years ]
    Health economic analysis assessed using EQ-5D health utility questionnaire and total healthcare costs.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 1, 2015)
  • Change in planned management [ Time Frame: 5 years ]
    Assess change in planned management with actual treatment delivered in both pre-operative PET-CT versus no PET-CT (control) patients.
  • Clinical and pathology response to chemotherapy using interim response of FDG PET-CT after 2 cycles of chemotherapy [ Time Frame: 5 years ]
    Explore if interim response on FDG PET-CT after 2 cycles of chemotherapy is associated with clinical and pathology response to chemotherapy and if early interim metabolic response correlates with other outcome measures including DFS and OS.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
Official Title  ICMJE Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
Brief Summary Bladder cancer is the fifth most common cancer in Canada and there has been relatively little progress in altering its clinical course over the last three decades. One of the major problems identified in the management of this disease, is under staging of muscle invasive disease which can lead to suboptimal treatment and outcomes. PET-CT has the potential to more accurately stage MIBC than standard CT by detecting pelvic adenopathy and/or distant sites of disease that may not be found on standard imaging. In the former situation, more aggressive therapy with extended lymph node dissection and/or neoadjuvant chemotherapy prior to cystectomy can be offered. While in the latter situation patients can be spared the morbidity of a cystectomy performed in a setting of metastatic disease. This study will address whether PET-CT adds a clinically meaningful difference in care.
Detailed Description A multicenter randomized controlled trial will be performed. Patients usually present with symptoms (e.g., painless hematuria). The urologist will perform cystoscopy and if urothelial cancer of the bladder is suspected, the patient is taken to the operating room for an examination under anesthesia (EUA) and a TURBT. If this shows muscle invasion then conventional staging with CT chest, abdomen, and pelvis is performed. The patient who has TNM Stage T2a-T4a N0-3 M0 is eligible to be enrolled in the trial. Eligible consenting patients will be randomized 2:1 to PET-CT or none (Control). The actual treatment received by the patient will be documented. The primary outcome measure is treatment received.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Muscle-invasive Bladder Cancer
Intervention  ICMJE Other: Whole-body FDG PET-CT
Other Name: PET-CT imaging
Study Arms  ICMJE
  • Experimental: Whole-body FDG PET-CT
    Whole-body FDG PET-CT (Experimental arm)
    Intervention: Other: Whole-body FDG PET-CT
  • No Intervention: No PET-CT
    No PET-CT (Control arm)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2015)
291
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women with newly diagnosed muscle-invasive high grade urothelial carcinoma of the bladder (TNM stage T2a-T4a, N0-3, M0), who are eligible for either radical cystectomy or radiotherapy-based bladder conservation.
  • Being considered for treatment of curative intent.

Exclusion Criteria:

  • Age < 18 years.
  • ECOG performance status >2.
  • Predominant histology (>50% of specimen) involves non-urothelial cell carcinoma.
  • Prior partial cystectomy.
  • Prior pelvis surgery that obviates a completed extended lymphadenectomy (e.g., aorto-femoral/iliac bypass) or for whom the surgeon feels that their ability to perform a standard or extended pelvic node dissection would be compromised.
  • Contraindications to FDG PET-CT.
  • Inability to lie supine for imaging with PET-CT.
  • Inadequate hepatic function:

    (i) Bilirubin >1.5 X ULN and (ii) SGOT and Alkaline phosphatase >3 X ULN

  • History of another invasive malignancy within the previous 5 years with the exception of non-melanoma skin cancer.
  • Known pregnancy or lactating female.
  • Inability to complete the study or required follow-up.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marc L Filion, MSc, CCRP 905-527-2299 ext 42611 filion@mcmcaster.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02462239
Other Study ID Numbers  ICMJE OCOG-2013-PETMUSE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ontario Clinical Oncology Group (OCOG)
Study Sponsor  ICMJE Ontario Clinical Oncology Group (OCOG)
Collaborators  ICMJE Cancer Care Ontario
Investigators  ICMJE
Principal Investigator: Srikala Sridhar, MD Princess Margaret Hospital, Canada
Principal Investigator: Nicholas Power, MD LHSC-Victoria Hospital
Principal Investigator: Som Mukherjee, MD Juravinski Cancer Centre
Principal Investigator: Ur Metser, MD Princess Margaret Hospital, Canada
Study Director: Mark Levine, MD Ontario Clinical Oncology Group (OCOG)
PRS Account Ontario Clinical Oncology Group (OCOG)
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP