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

Who is this study for? Adult patients with Pure or Mixed Urothelial Bladder Cancer
What treatments are being studied? Radiotherapy
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

Locations
Other Locations
France
Clinique Claude Bernard
RECRUITING
Albi
Institut de Cancerologie de L'Ouest
RECRUITING
Angers
CHU Besançon
RECRUITING
Besançon
Institut Bergonie
RECRUITING
Bordeaux
CHRU Brest
RECRUITING
Brest
Clinique Pasteur-Lanroze
RECRUITING
Brest
Centre Francois Baclesse
RECRUITING
Caen
Centre Jean Perrin
WITHDRAWN
Clermont-ferrand
Institut Andrée Dutreix
RECRUITING
Dunkirk
Centre Oscar Lambret
WITHDRAWN
Lille
Institut Paoli-Calmettes
RECRUITING
Marseille
Centre Antoine Lacassagne
RECRUITING
Nice
Groupe Hospitalier Paris Saint-Joseph
NOT_YET_RECRUITING
Paris
Institut Curie
RECRUITING
Paris
Groupement de Radiothérapie et d'Oncologie des Pyrénées
WITHDRAWN
Pau
Institut de Cancerologie de L'Ouest
RECRUITING
Saint-herblain
HIA Bégin
RECRUITING
Saint-mandé
Institut de Cancerologie Lucien Neuwirth
NOT_YET_RECRUITING
Saint-priest-en-jarez
Institut Universitaire du Cancer Toulouse Oncopole
RECRUITING
Toulouse
Institut Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Jonathan KHALIFA
khalifa.jonathan@iuct-oncopole.fr
05 31 15 54 01
Time Frame
Start Date: 2020-06-30
Estimated Completion Date: 2031-07
Participants
Target number of participants: 130
Treatments
No_intervention: Control arm
Standard of care
Experimental: Experimental arm
Related Therapeutic Areas
Sponsors
Leads: Institut Claudius Regaud

This content was sourced from clinicaltrials.gov

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