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Risk Enabled Therapy After Initiating Neoadjuvant Chemotherapy for Bladder Cancer (RETAIN)
Sponsor: Fox Chase Cancer Center
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.
Official title: A Phase II Trial of Risk Enabled Therapy After Initiating Neoadjuvant Chemotherapy for Bladder Cancer (RETAIN BLADDER)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2016-02-24
Completion Date
2034-02
Last Updated
2024-12-24
Healthy Volunteers
No
Conditions
Interventions
Methotrexate
Administered Day 1 of each 14 day cycle for 3 cycles
Vinblastine
Administered Day 1 of each 14 day cycle for 3 cycles
Doxorubicin
Administered Day 1 of each 14 day cycle for 3 cycles
Cisplatin
Administered Day 1 of each 14 day cycle for 3 cycles
Intensity modulated radiation therapy (IMRT)
2.0 Gy per fraction to the whole bladder plus a margin for a total of 32 fractions (64.0 Gy). Radiation will be administered from Monday to Friday
Transurethral Resection of Bladder tumor
Performed at before and after AMVAC and after chemoradiation and intravesicle therapy
5-FU
Continuous 24hr Intravenous infusion days 1-5 and 16-20 with radiation treatment
Mitomycin C
Intravenous on day 1 with radiation treatment
Locations (4)
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Johns Hopkins
Baltimore, Maryland, United States
Sidney kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States