NCT02710734

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

A Phase II Trial of Risk Enabled Therapy After Initiating Neoadjuvant Chemotherapy for Bladder Cancer (RETAIN BLADDER)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This phase II trial studies how well maximal transurethral surgery (surgery performed with a special instrument inserted through the urethra) followed by accelerated methotrexate, vinblastine, doxorubicin hydrochloride, cisplatin, and radiation therapy work in treating patients with bladder cancer that has spread to the muscle. Drugs used in chemotherapy, such as methotrexate, vinblastine sulfate, doxorubicin hydrochloride, and cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Conditions

• Urothelial Carcinoma of the Bladder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-02-24
• Primary completion: 2027-02-01
• Completion: 2034-02-01
• First posted: 2016-03-17
• Last updated: 2024-12-24

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study