NCT07000084 · Alliance for Clinical Trials in Oncology
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)
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
BCG Solution
Given intravesically
PROCEDURE
Biopsy of Bladder
Undergo bladder biopsy
PROCEDURE
Cystoscopy
Undergo cystoscopy
PROCEDURE
Computed Tomography
Undergo CT Scan
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Biospecimen Collection
Undergo blood and urine sample collection
PROCEDURE
Transurethral Resection of Bladder Tumor
Undergo TURBT
DRUG
Gemcitabine
Given intravesically
Primary outcome measures
High Grade Recurrence-free survival (HG-RFS)
Time frame: Up to 5 years
HG-RFS will be calculated from randomization until the detection of a high-grade bladder cancer recurrence (biopsy proven intravesical recurrence or distant metastasis), cystectomy, or death, whichever occurs first. Patients who are alive and without documented high-grade recurrence will be censored at the time of last disease evaluation. HG-RFS will be compared between the two study arms using a stratified log-rank test. The treatment effect will be estimated with a hazard ratio (HR) and corresponding 95% confidence interval obtained from a stratified Cox model with treatment group (
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Fairbanks, Alaska
- Gilbert, Arizona
- Phoenix, Arizona
- Irvine, California
- Orange, California
- Washington D.C., District of Columbia
- Gainesville, Florida
- Jacksonville, Florida
- Coeur d'Alene, Idaho
- Post Falls, Idaho
- Sandpoint, Idaho
And 42 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
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.
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.
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.
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.
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.
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.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations