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

ConditionMuscle-Invasive Bladder Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • Standard of care

    Procedure/Surgery

    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.

Treatment groups

156 Participants
are divided into 3 treatment groups
Group A: Non-metastatic MIBCActive comparator 1 intervention
Group B: Oligo-metastatic MIBC on 18F-FDG-PET-CTExperimental treatment 1 intervention
Group C: Poly-metastatic MIBC on 18F-FDG-PET-CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Defined as the time from diagnosis of MIBC to death from any cause

Time frame
2 years

Secondary outcomes

1

The number of patients with acute toxicity

Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame
3 months
2

The number of patients with late toxicity

Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame
5 years
3

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.

Time frame
5 years
4

Distant metastasis-free survival

Defined as time of diagnosis until occurrence of distant metastasis on repeated imaging.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

Kom Op Tegen Kanker

Collaborator

Source ClinicalTrials.gov
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