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Recruiting NCT04724928

Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer

Phase II Interventional Muscle-Invasive Bladder Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metastasis directed therapy (MDT), Immunotherapy, Standard of care.
Who it may be relevant to
Registry conditions: Muscle-Invasive Bladder Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Radiation Metastasis 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.
  • Drug Immunotherapy
    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.
  • Procedure Standard 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.

Primary outcome measures

  • Overall survival [Time frame: 2 years]
Secondary outcome measures (9)
  • The number of patients with acute toxicity [Time frame: 3 months]
  • The number of patients with late toxicity [Time frame: 5 years]
  • Progression-free survival [Time frame: 5 years]
  • Distant metastasis-free survival [Time frame: 5 years]
  • Disease specific survival [Time frame: 5 years]
  • Patient reported quality of life as per EORTC-QLQ C30 [Time frame: 5 years]
  • Patient reported quality of life as per EORTC-QLQ BLM30 [Time frame: 5 years]
  • Sensitivity/specificity of 18F-FDG-PET-CT for the detection of extra-pelvic metastases [Time frame: 3 months]
  • Validation of predictive biomarkers [Time frame: 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Ghent University Hospital — Ghent

Publications

  • 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( PMID 34663254

Identifiers

NCT: NCT04724928 · BC-07456 · BC-07456

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗