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NCT03609216RECRUITINGIRB Ready

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

Sponsored by Alliance for Clinical Trials in Oncology

Quick Self-Assessment

See if you qualify and express your interest

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Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Step 1 Patient Registration Eligibility Criteria
Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or examination under anesthesia (EUA). The diagnostic TURBT sample must have been obtained within 60 days prior to registration
20 unstained slides (10 micron thickness) of formalin-fixed paraffin-embedded (FFPE) pre-treatment diagnostic transurethral resection (TUR) specimen available (for sequencing), with 2 (5 micron) slides at the start and end of the 20 slides, for a total of 22 unstained slides. An FFPE block is also acceptable
Clinical stage T2-T4aN0/xM0 disease
Medically appropriate candidate for radical cystectomy as assessed by surgeon
No concomitant multifocal carcinoma in situ; a single focus is allowed
A single muscle-invasive bladder tumor measuring โ‰ค5

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

271 participants

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Gender

ALL

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Sponsor

Alliance for Clinical Trials in Oncology

Study Locations

Choose your preferred location or select flexible during enrollment

ACTIVE_NOT_RECRUITING

Fairbanks

Alaska

Location available
View Fairbanks location page
ACTIVE_NOT_RECRUITING

Goodyear

Arizona

Location available
View Goodyear location page
RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Fort Smith

Arkansas

Location available
View Fort Smith location page
SUSPENDED

Hot Springs

Arkansas

Location available
View Hot Springs location page
RECRUITING

Little Rock

Arkansas

Location available
View Little Rock location page
RECRUITING

Arroyo Grande

California

Location available
View Arroyo Grande location page
RECRUITING

Carmichael

California

Location available
View Carmichael location page
RECRUITING

Carmichael

California

Location available
View Carmichael location page

๐Ÿ“ And 414 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Bladder Cancer Treatment in Fairbanks?

Join others in Alaska exploring innovative treatment options through clinical research

Bladder Cancer Treatment Options in Fairbanks, Alaska

If you're searching for Bladder Cancer treatment in Fairbanks, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Fairbanks, Goodyear, Phoenix and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Bladder Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alaska
Now Enrolling
Up to 271 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Bladder Cancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Bladder Cancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Bladder Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT03609216. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.