About this trial
The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of bladder preservation as well as to decrease complications in patients with muscle invasive bladder cancer who wish to retain their bladders
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Karnofsky performance status > 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;
WBC equal or greater than 3500 mm3; platelet count equal or greater than 135000 mm3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0.
Disqualifiers
Prior radiation therapy to the target areas;
Inability to undergo a MRI exam
Trial design
Single group
Treatments tested in this trial
MR-guided Radiation Therapy
RadiationMR-guided Radiation Therapy
Treatment groups
Trial outcomes
Primary outcomes
Pathological complete response rate and Urinary and Rectal Toxicity
A. To achieve pathological complete response rate in 95% of the patients. B. To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
Secondary outcomes
Blood and urine biomarkers, Radiomics biomarkers and PROMs
A. Determination of blood and urine biomarkers of treatment response and toxicity . B. Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of urinary functionality with IPSS and Bladder Control Self-Assessment Questionnaire
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: