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

NCT02710734 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-05-22

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Fox Chase Cancer Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-24
Primary Completion
2025-11-27
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02710734 on ClinicalTrials.gov