Prospective Multicentric Evaluation of a Bladder Preservation Strategy
Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Radical cystectomy is the treatment of choice for bladder infiltrative urothelium carcinoma.
But the removal of the bladder reservoir has a major impact of the Quality of life.
Neoadjuvant chemotherapy has been shown to be associated with an absolute 5% survival
benefit. Two monocentric studies suggest that this neoadjuvant chemotherapy could be used in
combination with an optimal transurethral bladder resection, in a strategy of bladder
preservation, provided a complete response being obtained (about 50% in every trial using
neoadjuvant MVAC protocol before a radical cystectomy). In those both studies with patients
T2 to T4, the 5 years overall survival is above 65%, with more than 40% bladder preservation
rate at 5 years.
The feasibility and the efficacy of such an attitude in a multicentric trail using the most
active regimen (in term of complete response in metastatic patients) is unknown. The chosen
regimen is therefore the intensified MVAC which allows, with the use of G-CSF, to double the
dose-intensity of Adriamycin and Cisplatinum, and to decrease by 30% the methotrexate and
vinblastine dose-intensity.
The efficacy and safety confirmation of such an approach could lead to consider it in
patients motivated to retain a functional bladder.