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Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy

(GAIN-BCG)

Sponsored by Alliance for Clinical Trials in Oncology

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 4, 2026

Phase

Clinical Trial

Sponsor

Alliance for Clinical Trials in Oncology

Enrollment Target

330

Start Date

Jun 2025

๐Ÿ“Š
1 of 330 participants interested
0% interest

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 III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells.

Who Can Participate

Inclusion Criteria

Documentation of Disease: Histologic confirmation of urothelial carcinoma that is high grade Ta, high grade T1, or Tis (Tis/carcinoma in situ \[CIS\] only disease) within 120 days prior to randomization
Any component of neuroendocrine carcinoma (i.e., small cell or large cell) is not allowed. Other histologic subtypes/variant histologies are allowed so long as there is a predominantly urothelial component. \
Note: Pure squamous cell carcinoma or pure adenocarcinoma without a urothelial component are not allowed
All visible papillary lesions must be macroscopically resected by TURBT within 90 days of randomization. (Residual CIS is permitted). \
If the treating urologist did not perform the TURBT, the treating urologist must perform a cystoscopy within 45 days prior to randomization to confirm the absence of visible papillary disease
All patients with high grade T1 must undergo a restaging TURBT within 90 days of randomization. Patients who undergo a

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

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

330 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Alliance for Clinical Trials in Oncology

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
RECRUITING

Gilbert

Arizona

Location available
View Gilbert location page
RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Irvine

California

Location available
View Irvine location page
RECRUITING

Orange

California

Location available
View Orange location page
RECRUITING

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page
RECRUITING

Gainesville

Florida

Location available
View Gainesville location page
RECRUITING

Jacksonville

Florida

Location available
View Jacksonville location page
RECRUITING

Coeur d'Alene

Idaho

Location available
View Coeur d'Alene location page

๐Ÿ“ And 44 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

Find More Bladder Cancer Trials by City

Browse all bladder cancer clinical trials in these cities โ€” not just this study.

Looking for Bladder Cancer Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Bladder Cancer Treatment Options in Birmingham, Alabama

If you're searching for Bladder Cancer treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Gilbert, Gainesville 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 Alabama
Now Enrolling
Up to 330 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: NCT07000084. 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.