Muscle-Invasive Bladder Carcinoma
Conditions
Keywords
18F-FDG-PET-CT, Staging, Distand metastasis, Oligometastatic disease, Metastasis directed therapy, Immunotherapy
Brief summary
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.
Interventions
RADIATIONMetastasis directed therapy (MDT)
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.
DRUGImmunotherapy
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.
PROCEDUREStandard of care
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.
Sponsors
Kom Op Tegen Kanker
University Hospital, Ghent
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histopathology-proven MIBC on TURb or ≥ T3 on conventional imaging treated with MIBC radical treatment * T1-4 N0-3 M0 MIBC on conventional imaging (thoracic CT and abdominopelvic CT/ MRI) * Age \> 18 years * WHO 0-2 * Willingness to undergo 18F-FDG-PET-CT * Willingness to undergo MDT or immunotherapy, in case of diagnosis of oligometastatic or polymetastatic disease on 18F-FDG-PET-CT, respectively * Willingness and ability to provide a signed informed consent according to ICH/GCP and national/local regulations
Exclusion criteria
* Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT/ MRI) * Refusal of or having contraindications to 18F-FDG-PET-CT * Refusal of MDT or immunotherapy * Prior radiotherapy unabling MDT * Contraindications to radiotherapy (including active inflammatory bowel disease) * Contraindications to immunotherapy * Other primary tumor diagnosed \< 5 years ago and for which treatment is still required, except for diagnosis of non-metastatic prostate cancer at time of diagnosis of MIBC or non-melanoma skin cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | Defined as the time from diagnosis of MIBC to death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients with late toxicity | 5 years | Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| Progression-free survival | 5 years | 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. |
| Distant metastasis-free survival | 5 years | Defined as time of diagnosis until occurrence of distant metastasis on repeated imaging. |
| Disease specific survival | 5 years | Defined as time of diagnosis until death due to MIBC. |
| The number of patients with acute toxicity | 3 months | Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| Patient reported quality of life as per EORTC-QLQ BLM30 | 5 years | Validated questionnaire assessing the health-related QOL of muscle invasive bladder cancer patients |
| Sensitivity/specificity of 18F-FDG-PET-CT for the detection of extra-pelvic metastases | 3 months | Sensitivity/specificity of 18F-FDG-PET-CT |
| Validation of predictive biomarkers | 5 years | 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. |
| Patient reported quality of life as per EORTC-QLQ C30 | 5 years | Validated questionnaire assessing different health-related parameters (psychological, physical and social well-being) in cancer patients |
Countries
Belgium
Contacts
Primary ContactValerie Fonteyne, MD; PhD
Backup ContactFlor Verghote, MD
Outcome results
None listed