NCT02710734View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

February 24, 2016

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2034

Conditions
Urothelial Carcinoma of the Bladder
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

Trial Locations (4)

19107

Sidney kimmel Cancer Center, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

20010

Washington Cancer Institute at MedStar Washington Hospital Center, Washington D.C.

21287

Johns Hopkins, Baltimore

All Listed Sponsors
lead

Fox Chase Cancer Center

OTHER