Clinical trial NCT04724928: Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Muscle-Invasive Bladder Carcinoma
Keywords: 18F-FDG-PET-CT
Staging
Distand metastasis
Oligometastatic disease
Metastasis directed therapy
Immunotherapy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Kom Op Tegen Kanker
First posted: 2021-01-26
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: The number of patients with acute toxicity
timeFrame: 3 months
measure: The number of patients with late toxicity
timeFrame: 5 years
measure: Progression-free survival
timeFrame: 5 years
measure: Distant metastasis-free survival
timeFrame: 5 years
measure: Disease specific survival
timeFrame: 5 years
measure: Patient reported quality of life as per EORTC-QLQ C30
timeFrame: 5 years
measure: Patient reported quality of life as per EORTC-QLQ BLM30
timeFrame: 5 years
measure: Sensitivity/specificity of 18F-FDG-PET-CT for the detection of extra-pelvic metastases
timeFrame: 3 months
measure: Validation of predictive biomarkers
timeFrame: 5 years
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: UZ Ghent
name: Valerie Fonteyne, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.