Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer
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
University Hospital, Ghent
156 participants
Apr 29, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria7
- 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.
Interventions
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.
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04724928