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| ID | Type | Description | Link |
|---|---|---|---|
| BC-07456 | Other Identifier | Ethics committee of the Ghent University Hospital |
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| Name | Class |
|---|---|
| Kom Op Tegen Kanker | OTHER |
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Evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-metastatic MIBC | Active Comparator | No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) and 18F-FDG-PET-CT's |
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| Oligo-metastatic MIBC on 18F-FDG-PET-CT | Experimental | No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of ≤ 3 metastasis on 1 or both 18F FDG PET-CT 's |
|
| Poly-metastatic MIBC on 18F-FDG-PET-CT | Experimental | No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of > 3 metastasis on 1 or both 18F FDG PET-CT 's |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metastasis directed therapy (MDT) | Radiation | Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Concurrently, the oligometastasis will be treated with stereotactic body radiotherapy or metastasectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined as the time from diagnosis of MIBC to death from any cause | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients with acute toxicity | Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 3 months |
| The number of patients with late toxicity | Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valerie Fonteyne, MD; PhD | Contact | +3293323015 | valerie.fonteyne@uzgent.be | |
| Flor Verghote, MD | Contact | flor.verghote@uzgent.be |
| Name | Affiliation | Role |
|---|---|---|
| Valerie Fonteyne, MD; PhD | UZ Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Recruiting | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34663254 | Derived | Verghote F, Poppe L, Verbeke S, Dirix P, Albersen M, De Meerleer G, Berghen C, Ost P, Villeirs G, De Visschere P, De Man K, De Maeseneer D, Rottey S, Van Praet C, Decaestecker K, Fonteyne V. Evaluating the impact of 18F-FDG-PET-CT on risk stratification and treatment adaptation for patients with muscle-invasive bladder cancer (EFFORT-MIBC): a phase II prospective trial. BMC Cancer. 2021 Oct 18;21(1):1113. doi: 10.1186/s12885-021-08861-x. |
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| Immunotherapy | Drug | Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Afterwards immunotherapy will be initiated and regular follow up will be performed. |
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| Standard of care | Procedure | Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Afterwards regular follow up is performed. |
|
| 5 years |
| Progression-free survival | Defined as appearance of local/locoregional recurrence diagnosed at CT-scan or cystoscopy in case of TMT or appearance of metastasis diagnosed at MIBC or non-MIBC-related imaging. | 5 years |
| Distant metastasis-free survival | Defined as time of diagnosis until occurrence of distant metastasis on repeated imaging. | 5 years |
| Disease specific survival | Defined as time of diagnosis until death due to MIBC. | 5 years |
| Patient reported quality of life as per EORTC-QLQ C30 | Validated questionnaire assessing different health-related parameters (psychological, physical and social well-being) in cancer patients | 5 years |
| Patient reported quality of life as per EORTC-QLQ BLM30 | Validated questionnaire assessing the health-related QOL of muscle invasive bladder cancer patients | 5 years |
| Sensitivity/specificity of 18F-FDG-PET-CT for the detection of extra-pelvic metastases | Sensitivity/specificity of 18F-FDG-PET-CT | 3 months |
| Validation of predictive biomarkers | A biopsy specimen of the bladder, obtained after transurethral resection of the bladder (TURb),as well as urine and blood samples will be collected for validation of predictive biomarkers by evaluating the correlation between response to therapy and outcome (PFS, DMFS, DSS and OS) with in literature reported biomarkers determined on biopsy specimen of the bladder, obtained after TURb. | 5 years |
| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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