MedTrace Logo

Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations

NCT03609216 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2026-04-13

No results posted yet for this study

Summary

This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine 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.

Conditions

  • Infiltrating Bladder Urothelial Carcinoma
  • Stage II Bladder Urothelial Carcinoma
  • Stage III Bladder Urothelial Carcinoma

Interventions

DRUG

Gemcitabine Hydrochloride

Given IV

DRUG

Cisplatin

Given IV

BIOLOGICAL

Pegfilgrastim

Given SC

PROCEDURE

Conventional Surgery

Undergo bladder sparing

PROCEDURE

Radical Cystectomy

Undergo radical cystectomy

OTHER

Chemoradiotherapy

Undergo chemoradiotherapy

Sponsors & Collaborators

Principal Investigators

  • Gopa Iyer, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2027-02-01
Completion
2029-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03609216 on ClinicalTrials.gov