CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 156 target
Drug / intervention
Immunotherapy +2 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • Histopathology-proven MIBC on TURb or ≥T3 on imaging
  • T1-4 N0-3 M0 MIBC staging on conventional imaging
  • Age over 18 years
  • Willingness to undergo 18F-FDG-PET-CT imaging
Key exclusion· 7
  • Distant metastasis on conventional imaging
  • Refusal or contraindications to 18F-FDG-PET-CT
  • Refusal of MDT or immunotherapy
  • Prior radiotherapy preventing MDT delivery

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04724928
NCT04724928Phase 2RecruitingOn TrackUpdated 17mo ago
Long Recruiting

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·interventional·Posted Jan 26, 2021·Updated Jan 15, 2025

In Brief

A Phase 2 clinical trial evaluating Metastasis directed therapy (MDT), Immunotherapy, and 1 other intervention for Muscle-Invasive Bladder Carcinoma. Currently recruiting, targeting 156 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
CollaboratorsKom Op Tegen Kanker

Timeline

Phase 2Recruiting
2021202220232024202520262027202820292030
First PostedJan 26, 2021
Enrollment StartApr 29, 2021
Primary CompletionDec 31, 2029
Study CompletionMay 1, 2030
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 5.4 years agoPrimary completion in 3.5 years

Interventions

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.

Immunotherapydrug

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 careprocedure

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.