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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)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Muscle-invasive Bladder Cancer Other: Whole-body FDG PET-CT Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
Study Start Date : January 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Whole-body FDG PET-CT
Whole-body FDG PET-CT (Experimental arm)
 Other: Whole-body FDG PET-CT
Other Name: PET-CT imaging
No Intervention: No PET-CT
No PET-CT (Control arm)


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. Overall survival [ Time Frame: 5 years ]
    Overall survival defined by all-cause mortality.

  3. Quality of life analysis [ Time Frame: 5 years ]
    Overall QOL assessed using the EORTC QLQ-C30 version 3.

  4. Health economic analysis [ Time Frame: 5 years ]
    Health economic analysis assessed using EQ-5D health utility questionnaire and total healthcare costs.


Other Outcome Measures:
  1. 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.

  2. 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.


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

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.
Contacts and Locations
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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): NCT02462239


Contacts
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Contact: Marc L Filion, MSc, CCRP 905-527-2299 ext 42611 filion@mcmcaster.ca

Locations
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Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Som Mukherjee, MD    905-387-9495    mukherjee@hhsc.ca   
Principal Investigator: Som Mukherjee, MD         
London Regional Cancer Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Nick Power, MD       Nicholas.Power@lhsc.on.ca   
Principal Investigator: Eric Winquist, MD         
Ottawa Hospital Regional Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Rodney Breau, MD    613-737-8899    rbreau@ottawahospital.on.ca   
Principal Investigator: Rodney Breau, MD         
Thunder Bay Regional Health Sciences Centre Recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Dolores Sicheri, MD       sicherid@tbh.net   
Principal Investigator: Dolores Sicheri, MD         
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Susanna Cheng, MD    416-480-4928    susanna.cheng@sunnybrook.ca   
Principal Investigator: Susanna Cheng, MD         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Srikala Sridhar, MD       Srikala.Sridhar@uhn.ca   
Principal Investigator: Srikala Sridhar, MD         
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Cancer Care Ontario
Investigators
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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)
More Information
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Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT02462239     History of Changes
Other Study ID Numbers: OCOG-2013-PETMUSE
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Muscle-invasive bladder cancer
Bladder cancer
PET imaging
FDG

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type