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NCT03609216 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Infiltrating Bladder Urothelial Carcinoma and Stage II Bladder Urothelial Carcinoma, sponsored by Alliance for Clinical Trials in Oncology.

Recruiting
Registry status
Phase 2
Development phase
271
Enrollment target
20
Study locations

NCT03609216 is a Phase 2 study of Infiltrating Bladder Urothelial Carcinoma and Stage II Bladder Urothelial Carcinoma that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 271 participants. The trial reports 20 study locations across 4 states.

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The verdict

NCT03609216, a Phase 2 study of Infiltrating Bladder Urothelial Carcinoma and Stage II Bladder Urothelial Carcinoma, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.

RECRUITING
Registry status
Phase 2
Development phase
271 participants
Enrollment target
20
Study locations

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.

Interventions

  • DRUG Cisplatin
  • BIOLOGICAL Pegfilgrastim
  • DRUG Gemcitabine Hydrochloride
  • PROCEDURE Conventional Surgery
  • PROCEDURE Radical Cystectomy

Study Locations (20)

California

  • Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
  • Mercy Cancer Center - Carmichael - Carmichael
  • Mercy San Juan Medical Center - Carmichael
  • Mercy Cancer Center - Elk Grove - Elk Grove
  • Cedars Sinai Medical Center - Los Angeles
  • Contra Costa Regional Medical Center - Martinez
  • Fremont - Rideout Cancer Center - Marysville
  • Mercy Cancer Center - Merced
  • Mercy Cancer Center - Rocklin - Rocklin
  • Mercy Cancer Center - Sacramento - Sacramento
  • University of California Davis Comprehensive Cancer Center - Sacramento
  • Pacific Central Coast Health Center-San Luis Obispo - San Luis Obispo
  • Mission Hope Medical Oncology - Santa Maria - Santa Maria
  • Saint Joseph's Medical Center - Stockton

Arkansas

  • Mercy Hospital Fort Smith - Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
  • University of Arkansas for Medical Sciences - Little Rock

Arizona

  • CTCA at Western Regional Medical Center - Goodyear
  • Cancer Center at Saint Joseph's - Phoenix

Alaska

  • Fairbanks Memorial Hospital - Fairbanks

Trial Details

FieldValue
Enrollment Target 271 participants
Start Date 2018-12-10
Est. Completion 2029-02-01
Phase Phase 2

What the Registry Record Tells You About NCT03609216

The ClinicalTrials.gov registry entry for NCT03609216 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 271 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Infiltrating Bladder Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.

NCT03609216 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arkansas, Arizona.

Frequently Asked Questions

What is clinical trial NCT03609216 about?

NCT03609216 is a clinical study titled "Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations". 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...

What is the current status of trial NCT03609216?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 271 participants. The study started on 2018-12-10. Estimated completion is 2029-02-01.

What conditions does trial NCT03609216 study?

This clinical trial studies the following conditions: Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma.

What interventions are being tested in trial NCT03609216?

The interventions under investigation include: Cisplatin (DRUG), Pegfilgrastim (BIOLOGICAL), Gemcitabine Hydrochloride (DRUG), Conventional Surgery (PROCEDURE), Radical Cystectomy (PROCEDURE).

Who is sponsoring clinical trial NCT03609216?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03609216 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.