Actively Recruiting
Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy
Led by Institut Claudius Regaud · Updated on 2025-11-18
130
Participants Needed
20
Research Sites
574 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase II, multicenter, randomized open-label and comparative study that has been designed to evaluate whether local consolidative radiotherapy in addition to standard of care improves overall survival as compared with standard of care in patients with regional and/or distant metastatic urothelial bladder cancer who have no disease progression and with no more than three residual distant metastatic lesions following the initial phase of first-line systemic therapy. Each patient will be followed during 4 years from the date of randomization.
CONDITIONS
Official Title
Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Histologically confirmed urothelial bladder cancer (including pure and mixed types)
- Metastatic disease to regional lymph nodes and/or distant sites documented by CT scan
- Completed initial phase of 4-6 cycles of first-line metastatic systemic therapy
- No disease progression after initial systemic therapy according to RECIST v1.1
- No more than three residual distant metastatic lesions after initial systemic therapy
- Residual distant metastases eligible for stereotactic body radiotherapy (SBRT) with no prior conflicting radiotherapy
- Randomization within 8 weeks after last cycle of initial systemic treatment
- No contraindication to pelvic radiotherapy
- Signed informed consent
- Able and willing to comply with study protocol
- Affiliated with a Social Health Insurance in France
You will not qualify if you...
- Non-transitional cell histology such as squamous cell carcinoma, adenocarcinoma, or neuroendocrine carcinoma
- Brain metastases before systemic treatment
- Liver metastases before systemic treatment
- No target for irradiation due to previous cystectomy and no residual lesions
- Relapse after definitive chemoradiation of the bladder
- Local recurrence in the cystectomy bed
- Previous pelvic irradiation
- Prior radiotherapy near residual metastatic lesions precluding SBRT
- Active inflammatory bowel disease
- Contraindication to SBRT due to organ dysfunction or lung disease
- History of scleroderma
- Second neoplasm diagnosed within last 5 years except certain low-risk cancers
- Pregnancy, breastfeeding, or inadequate contraception
- Psychiatric or substance abuse disorders interfering with study cooperation
- Psychological, familial, geographic, or social situations preventing informed consent or compliance
- Legal restrictions on freedom or protection status
- Concurrent participation in another interventional therapeutic clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Clinique Claude Bernard
Albi, France
Actively Recruiting
2
Institut de Cancerologie de L'Ouest
Angers, France
Actively Recruiting
3
CHU Besançon
Besançon, France
Actively Recruiting
4
Institut Bergonie
Bordeaux, France
Actively Recruiting
5
CHRU Brest
Brest, France
Actively Recruiting
6
Clinique Pasteur-Lanroze
Brest, France
Actively Recruiting
7
Centre Francois Baclesse
Caen, France
Actively Recruiting
8
Centre Jean Perrin
Clermont-Ferrand, France
Withdrawn
9
Institut Andrée Dutreix
Dunkirk, France
Actively Recruiting
10
Centre Oscar Lambret
Lille, France
Withdrawn
11
Institut Paoli-Calmettes
Marseille, France
Actively Recruiting
12
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
13
Groupe Hospitalier Paris Saint-Joseph
Paris, France
Not Yet Recruiting
14
Institut Curie
Paris, France
Actively Recruiting
15
Groupement de Radiothérapie et d'Oncologie des Pyrénées
Pau, France
Withdrawn
16
Institut de Cancerologie de L'Ouest
Saint-Herblain, France
Actively Recruiting
17
HIA Bégin
Saint-Mandé, France
Actively Recruiting
18
Institut de Cancerologie Lucien Neuwirth
Saint-Priest-en-Jarez, France
Not Yet Recruiting
19
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France
Actively Recruiting
20
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
J
Jonathan KHALIFA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here