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 |
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Recruitment Status :
Recruiting
First Posted : June 4, 2015
Last Update Posted : April 5, 2018
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Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborator:
Cancer Care Ontario
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
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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 |
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 : | 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
Genetics Home Reference related topics:
Bladder cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Whole-body FDG PET-CT
Whole-body FDG PET-CT (Experimental arm)
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Other: Whole-body FDG PET-CT
Other Name: PET-CT imaging |
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No Intervention: No PET-CT
No PET-CT (Control arm)
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Primary Outcome Measures :
- 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 :
- 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.
Other Outcome Measures:
- 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.
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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.
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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.
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
| Contact: Marc L Filion, MSc, CCRP | 905-527-2299 ext 42611 | filion@mcmcaster.ca |
Locations
| 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
| 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) |
| 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):
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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 |