Overview

Risk Enabled Therapy After Initiating Neoadjuvant Chemotherapy for Bladder Cancer (RETAIN)

Status:
Active, not recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
The aim of this study is to evaluate a risk-adapted approach to the treatment of muscle invasive bladder cancer. Each baseline transuretheral resection of bladder tumor (TURBT) sample will be sequenced while proceeding with neoadjuvant accelerated methotrexate, vinblastine, doxorubicin, and cisplatin (AMVAC) chemotherapy. Based on the mutational profile and the post AMVAC TURBT findings, patients will be treated with active surveillance (experimental arm), or standard of care intravesicle therapy, chemoradiation or surgery. We hypothesize that this approach will lead to non-inferior metastasis-free survival at 2 years, while preserving the bladder and thus quality-of-life for a proportion of patients.
Phase:
Phase 2
Details
Lead Sponsor:
Fox Chase Cancer Center
Treatments:
Cisplatin
Doxorubicin
Liposomal doxorubicin
Methotrexate
Mitomycin
Mitomycins
Vinblastine