RecruitingPhase 2NCT04428554

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

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


Sponsor

Institut Claudius Regaud

Enrollment

130 participants

Start Date

Jun 30, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether targeted radiation therapy (called SBRT) given after standard chemotherapy or immunotherapy can help control bladder cancer that has spread to a small number of sites in the body. **You may be eligible if...** - You are 18 or older - You have been diagnosed with bladder cancer (urothelial type) that has spread to lymph nodes or other parts of the body - You completed 4–6 cycles of first-line chemotherapy or immunotherapy for metastatic disease, and your cancer did not get worse during treatment - You have 3 or fewer remaining cancer spots visible on scans after treatment - Your cancer has not come back in your original surgical area (if you had your bladder removed) **You may NOT be eligible if...** - Your bladder cancer is a rare type (squamous cell, adenocarcinoma, or neuroendocrine) - You had brain or liver metastases before starting systemic treatment - You have had prior pelvic radiation that would prevent safe retreatment - You have active inflammatory bowel disease or a history of scleroderma - You have been diagnosed with another cancer in the past 5 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONExperimental arm

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


Locations(20)

Clinique Claude Bernard

Albi, France

Institut de Cancerologie de L'Ouest

Angers, France

CHU Besançon

Besançon, France

Institut Bergonie

Bordeaux, France

CHRU Brest

Brest, France

Clinique Pasteur-Lanroze

Brest, France

Centre Francois Baclesse

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

Institut Andrée Dutreix

Dunkirk, France

Centre Oscar Lambret

Lille, France

Institut Paoli-Calmettes

Marseille, France

Centre Antoine Lacassagne

Nice, France

Groupe Hospitalier Paris Saint-Joseph

Paris, France

Institut Curie

Paris, France

Groupement de Radiothérapie et d'Oncologie des Pyrénées

Pau, France

Institut de Cancerologie de L'Ouest

Saint-Herblain, France

HIA Bégin

Saint-Mandé, France

Institut de Cancerologie Lucien Neuwirth

Saint-Priest-en-Jarez, France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

Institut Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT04428554


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