Urothelial Bladder CancerPhase 2BLAD-RAD01NCT04428554
Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy
A Phase 2 study testing Experimental arm in people with Urothelial Bladder Cancer, run by Institut Claudius Regaud at 20 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Bladder Cancer
- What is being tested?
- Experimental arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 20 sitesFrance
- Study dates
- 30 Jun 2020to Jul 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Urothelial bladder cancer histologically proven (both pure urothelial cancers and mixed histologic features are allowed)
- Metastatic patients to regional nodes (Tx,N1-N3,M0) and/or distant sites (Tx,Nx,M1a-M1b) documented with contrast-enhanced CT-scanner of the chest, abdomen and pelvis, either de novo or presenting first regional/distant relapse following cystectomy (with no local recurrence in the cystectomy bed)
- Completion of the initial phase (4-6 cycles) of 1st line metastatic treatment (systemic therapy by chemotherapy and/or immunotherapy by immune check-point inhibitor according to standard recommendations). Patients having started maintenance therapy are eligible.
- No disease progression after the initial phase of first-line metastatic systemic therapy according to RECIST v1.1
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- No more than 3 residual distant metastatic lesions following the initial phase of first-line metastatic systemic therapy:
- Regional nodes (below aortic bifurcation) are not included in the count of distant metastatic lesions
- The number of distant residual lesions is determined on the basis of the imaging modality for tumor response assessment performed after systemic treatment according to local habits (CT-scan or 18FDG PET-CT if performed):
- In case of response assessment by CT-scanner only: residual lesions are all remaining visible lesions In case of response assessment by additional 18FDG PET-CT: residual lesions are only the lesions with residual hyperfixation
- Regarding distant lymph nodes metastases:
- If evaluation is performed by CT-scanner only, residual lymph nodes are considered pathological according to one or several criteria among: Short axis ≥ 1cm/Central necrosis/Heterogeneous contrast enhancement
- Residual para-aortic nodes involvement accounts for one lesion, even if several para-aortic nodes are involved.
- Other nodes: each involved node accounts for one lesion.
- Residual distant metastases (if applicable) eligible for SBRT in terms of dose constraints to the organs at risk, with no prior radiotherapy interfering with SBRT
- 8 weeks or less between last cycle of the initial phase of systemic treatment and randomization
- No contraindication to pelvic radiotherapy
- Signed informed consent
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
- Patient affiliated to a Social Health Insurance in France
Who cannot join
- Non-transitional cell histology (Squamous cell carcinoma, adenocarcinoma or neuroendocrine carcinoma of the bladder)
- Brain metastases before systemic treatment
- Liver metastases before systemic treatment
- Absence of target to be irradiated (i.e. previous cystectomy + no residual distant lesions following systemic treatment + no pelvic or para-aortic nodes at metastatic presentation)
- Patient with relapse following definitive chemoradiation of the bladder
- Local recurrence in the cystectomy bed following cystectomy
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- Previous pelvic irradiation
- Prior radiotherapy near the residual metastatic lesions precluding ablative SBRT
- Active inflammatory bowel disease
- Contraindication to SBRT of a lesion due to organ dysfunction; in particular, patients with lung lesions and documented or suspected interstitial lung disease should not be included
- History of scleroderma
- Current or past history of second neoplasm diagnosed within the last 5 years (except basocellular carcinoma and prostate cancer incidentally discovered during previous cystoprostatetectomy and pelvic lymph node dissection and with a good prognosis [T stage <pT3b and Gleason <8 and pN- and post-operative PSA <0.1 ng/mL])
- Pregnancy or breast feeding or inadequate contraceptive measures
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
- Concurrent enrolment in another interventional therapeutic clinical study
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 17 recruiting
- Recruiting
Clinique Claude Bernard
Albi
Laurent VOTRON, 05 63 77 77 56, votron@claude-bernard-albi.com
- Recruiting
Institut de Cancerologie de L'Ouest
Angers
Nathalie MESGOUEZ-NEBOUT, 02 41 35 27 00, thalie.mesgouez-nebout@ico-unicancer.fr
- Recruiting
CHU Besançon
Besançon
Jihane BOUSTANI, 03 70 63 23 23, jboustani@chu-besançon.fr
- Recruiting
Institut Bergonie
Bordeaux
Paul SARGOS, 05 56 33 33 33, P.Sargos@bordeaux.unicancer.fr
- Recruiting
CHRU Brest
Brest
Ulrike SCHICK, ulrike.schick@chu-brest.fr
- Recruiting
Clinique Pasteur-Lanroze
Brest
Matthieu CHASSERAY, 02 98 31 30 07, m.chasseray@oncologie-brest.fr
- Recruiting
Centre Francois Baclesse
Caen
Pierre-Emmanuel BRACHET, 02 31 45 50 02, pe.brachet@baclesse.unicancer.fr
- Withdrawn
Centre Jean Perrin
Clermont-Ferrand
- Recruiting
Institut Andrée Dutreix
Dunkirk
Thomas MULLIEZ, 03 28 51 96 30, thomasmulliez@hotmail.com
- Withdrawn
Centre Oscar Lambret
Lille
- Recruiting
Institut Paoli-Calmettes
Marseille
Naji SALEM, 04 91 22 36 37, salemn@ipc.unicancer.fr
- Recruiting
Centre Antoine Lacassagne
Nice
Médéric BARRET, 04 92 03 12 60, mederic.barret@nice.unicancer.fr
- Not yet recruiting
Groupe Hospitalier Paris Saint-Joseph
Paris
Constance MICHEL, Dr, 01 44 12 78 18, cmichel@ghpsj.fr
- Recruiting
Institut Curie
Paris
Gilles CREHANGE, 01 72 38 94 45, gilles.crehange@curie.fr
- Withdrawn
Groupement de Radiothérapie et d'Oncologie des Pyrénées
Pau
- Recruiting
Institut de Cancerologie de L'Ouest
Saint-Herblain
Valentine GUIMAS, 02 40 57 99 55, valentine.guimas@ico.unicancer.fr
- Recruiting
HIA Bégin
Saint-Mandé
Hugo PICCHI, 01 86 93 75 20, picchi.hugo90@gmail.com
- Not yet recruiting
Institut de Cancerologie Lucien Neuwirth
Saint-Priest-en-Jarez
Nicolas MAGNE, 04 77 91 74 25, nicolas.magne@icloire.fr
- Recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse
Jonathan KHALIFA, 05 31 15 54 29, khalifa.jonathan@iuct-oncopole.fr
- Recruiting
Institut Gustave Roussy
Villejuif
Pierre BLANCHARD, 01 42 11 44 13, pierre.blanchard@gustaveroussy.fr
About this study
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: a Prospective Randomized Comparative Phase II Trial
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
- Urothelial Bladder Cancer
- Being tested
- Experimental arm
- Keywords
- Urothelial bladder cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental armRadiation
Consolidative radiotherapy (pelvic irradiation and/or metastases irradiation) + standard of care +/- previous transurethral resection of bladder tumor
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Standard of care |
| Experimental arm | Experimental | Not described Receives: Radiation: Experimental arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 4 years for each patient
Secondary outcomes (3)
Progression Free Survival
Measured: 4 years for each patient
Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5)
Measured: 4 years for each patient
Quality of life will be evaluated by the EORTC QLQ-C-30 questionnaire
Measured: 4 years for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start30 Jun 2020
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428554
- Sponsor's protocol ID
- 19 URO 15
- Acronym
- BLAD-RAD01
- Status last verified
- Nov 2025
- First submitted
- 9 Jun 2020
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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: a Prospective Randomized Comparative Phase II Trial
- ClinicalTrials.gov ID
- NCT04428554
- Acronym / sponsor ID
- BLAD-RAD01 / 19 URO 15
- Conditions
- Urothelial Bladder Cancer
- Keywords
- Urothelial bladder cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Standard of care |
| Experimental arm | Experimental | Radiation: Experimental arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Urothelial bladder cancer histologically proven (both pure urothelial cancers and mixed histologic features are allowed)
- Metastatic patients to regional nodes (Tx,N1-N3,M0) and/or distant sites (Tx,Nx,M1a-M1b) documented with contrast-enhanced CT-scanner of the chest, abdomen and pelvis, either de novo or presenting first regional/distant relapse following cystectomy (with no local recurrence in the cystectomy bed)
- Completion of the initial phase (4-6 cycles) of 1st line metastatic treatment (systemic therapy by chemotherapy and/or immunotherapy by immune check-point inhibitor according to standard recommendations). Patients having started maintenance therapy are eligible.
Key exclusion criteria (17 listed)
- Non-transitional cell histology (Squamous cell carcinoma, adenocarcinoma or neuroendocrine carcinoma of the bladder)
- Brain metastases before systemic treatment
- Liver metastases before systemic treatment
- Absence of target to be irradiated (i.e. previous cystectomy + no residual distant lesions following systemic treatment + no pelvic or para-aortic nodes at metastatic presentation)
- Patient with relapse following definitive chemoradiation of the bladder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental armConsolidative radiotherapy (pelvic irradiation and/or metastases irradiation) + standard of care +/- previous transurethral resection of bladder tumor | Radiation | Experimental arm |
Primary outcome
Overall Survival
Time frame: 4 years for each patient
3 secondary outcomes
Progression Free Survival
Time frame: 4 years for each patient
Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5)
Time frame: 4 years for each patient
Quality of life will be evaluated by the EORTC QLQ-C-30 questionnaire
Time frame: 4 years for each patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental arm in people with Urothelial Bladder Cancer, run by Institut Claudius Regaud at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan KHALIFA (05 31 15 54 01, khalifa.jonathan@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 4 years for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.