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ACTIVE NOT RECRUITING
NCT02710734
PHASE2

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

Sponsor: Fox Chase Cancer Center

View on ClinicalTrials.gov

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

Interventions

DRUG

Methotrexate

Administered Day 1 of each 14 day cycle for 3 cycles

DRUG

Vinblastine

Administered Day 1 of each 14 day cycle for 3 cycles

DRUG

Doxorubicin

Administered Day 1 of each 14 day cycle for 3 cycles

DRUG

Cisplatin

Administered Day 1 of each 14 day cycle for 3 cycles

RADIATION

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

PROCEDURE

Transurethral Resection of Bladder tumor

Performed at before and after AMVAC and after chemoradiation and intravesicle therapy

DRUG

5-FU

Continuous 24hr Intravenous infusion days 1-5 and 16-20 with radiation treatment

DRUG

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