Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy

NCT04428554 | Recruiting Phase 2

• 1 other identifier: 19 URO 15
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 20

Brief 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 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

Keywords

Urothelial bladder cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  4 years for each patient

Secondary Outcomes (3)

• Progression Free Survival

  4 years for each patient

• Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5)

  4 years for each patient

• Quality of life will be evaluated by the EORTC QLQ-C-30 questionnaire

  4 years for each patient

Study Arms (2)

Control arm

NO INTERVENTION

Standard of care

Experimental arm

EXPERIMENTAL

Radiation: Experimental arm

Interventions

Experimental arm RADIATION

Consolidative radiotherapy (pelvic irradiation and/or metastases irradiation) + standard of care +/- previous transurethral resection of bladder tumor

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (20)

Clinique Claude Bernard

Albi, France

RECRUITING

Institut de Cancerologie de L'Ouest

Angers, France

RECRUITING

CHU Besançon

Besançon, France

RECRUITING

Institut Bergonie

Bordeaux, France

RECRUITING

CHRU Brest

Brest, France

RECRUITING

Clinique Pasteur-Lanroze

Brest, France

RECRUITING

Centre Francois Baclesse

Caen, France

RECRUITING

Centre Jean Perrin

Clermont-Ferrand, France

WITHDRAWN

Institut Andrée Dutreix

Dunkirk, France

RECRUITING

Centre Oscar Lambret

Lille, France

WITHDRAWN

Institut Paoli-Calmettes

Marseille, France

RECRUITING

Centre Antoine Lacassagne

Nice, France

RECRUITING

Groupe Hospitalier Paris Saint-Joseph

Paris, France

NOT YET RECRUITING

Institut Curie

Paris, France

RECRUITING

Groupement de Radiothérapie et d'Oncologie des Pyrénées

Pau, France

WITHDRAWN

Institut de Cancerologie de L'Ouest

Saint-Herblain, France

RECRUITING

HIA Bégin

Saint-Mandé, France

RECRUITING

Institut de Cancerologie Lucien Neuwirth

Saint-Priest-en-Jarez, France

NOT YET RECRUITING

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

RECRUITING

Institut Gustave Roussy

Villejuif, France

RECRUITING

Central Study Contacts

Jonathan KHALIFA

CONTACT

05 31 15 54 01; khalifa.jonathan@iuct-oncopole.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: June 30, 2020
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

FR (20)