Actively Recruiting
GAIN-BCG: Gemcitabine Alternating With Intravesical BCG Compared to BCG Alone for Patients With Recurrent High-Grade Non-Muscle Invasive Bladder Cancer
Led by Alliance for Clinical Trials in Oncology · Updated on 2026-06-02
330
Participants Needed
56
Research Sites
26 weeks
Total Duration
On this page
Sponsors
A
Alliance for Clinical Trials in Oncology
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of adding gemcitabine, a chemotherapy drug, to the usual intravesical Bacillus Calmette Guerin (BCG) treatment for patients with recurrent non-muscle invasive bladder cancer (NMIBC). This phase III trial aims to compare how well gemcitabine combined with BCG works versus BCG alone in preventing high-grade cancer recurrence and progression in patients whose cancer has returned after prior BCG therapy. Participants are randomly assigned to one of two treatment groups. One group receives BCG alone intravesically once a week for 6 weeks, followed by maintenance BCG treatments at months 3, 6, and 12 if there is no disease progression or toxicity. The other group receives gemcitabine intravesically on a scheduled basis combined with BCG on alternate weeks during the initial treatment phase and maintenance phases at months 3, 6, and 12. Both groups undergo bladder biopsy, transurethral resection of bladder tumor (TURBT), cystoscopy, CT or MRI scans, and blood and urine sample collection throughout the study. After completing treatment, participants are followed every 3 months for 2 years, then every 6 months for up to 5 years from randomization. Researchers will monitor high-grade recurrence-free survival as the primary outcome, along with measures such as cancer-free status at 3 months, 6-month complete response, progression-free survival, cystectomy-free survival, and safety including adverse events. Biobanking of tissue and samples will support future research. The study collects extensive clinical and imaging data to evaluate the treatments over time.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologic confirmation of high-grade urothelial carcinoma (Ta, T1, or carcinoma in situ) within 120 days before randomization
- All visible papillary tumors must be removed by TURBT within 90 days before randomization
- Restaging TURBT required for high-grade T1 patients within 90 days before randomization
- Recurrent high-grade non-muscle invasive bladder cancer within 24 months of last BCG exposure but not meeting BCG-unresponsive criteria
- Prior induction and maintenance BCG treatments allowed if not currently BCG-unresponsive
- Prior intravesical chemotherapy, including gemcitabine, allowed
- Prior systemic or intravesical treatments for NMIBC allowed
- No history of intolerance to BCG or other intravesical therapies
- No compromised bladder function preventing further intravesical therapy
- No muscle-invasive, locally advanced unresectable, or metastatic urothelial carcinoma
- History of treated upper tract urothelial carcinoma allowed if no residual disease
- Non-invasive prostatic urethral urothelial carcinoma allowed after TURP
- HIV-positive patients on effective therapy with undetectable viral load allowed
- Not pregnant or nursing; negative pregnancy test required for those of childbearing potential
- Prior or concurrent malignancies allowed if they do not interfere with study assessments
You will not qualify if you...
- Presence of any neuroendocrine carcinoma component
- Pure squamous cell carcinoma or pure adenocarcinoma without urothelial component
- Patients currently meeting BCG-unresponsive NMIBC criteria
- History of intolerance to BCG or other intravesical therapies
- Compromised bladder function unlikely to tolerate intravesical therapy
- Evidence of muscle-invasive, locally advanced unresectable, or metastatic urothelial carcinoma
- Pregnant or breastfeeding individuals
- Patients without proper tumor resection or restaging TURBT when required
- Patients with uncontrolled infections or unable to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive intravesical BCG alone or a combination of gemcitabine and BCG according to their assigned treatment arm. Treatment includes weekly or twice-weekly intravesical instillations over several weeks with additional treatment cycles at months 3, 6, and 12 if there is no disease progression or unacceptable toxicity. Participants undergo bladder biopsy, TURBT, cystoscopy, CT or MRI scans, and blood and urine sample collection throughout treatment.
Weekly visits during initial treatment weeks and additional visits at months 3, 6, and 12
Duration - Up to 5 years
After completing study treatment, participants are followed to monitor their health and cancer status. Follow-up visits occur every 3 months for 2 years, then every 6 months for up to 3 additional years, totaling up to 5 years from randomization.
Visits every 3 months for 2 years, then every 6 months for 3 years
Trial Site Locations
Total: 56 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
3
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
4
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
5
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
6
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
7
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
8
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Suspended
9
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
10
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Actively Recruiting
11
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Actively Recruiting
12
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
13
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
14
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
15
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, United States, 60160
Actively Recruiting
16
IU Health West Hospital
Avon, Indiana, United States, 46123
Actively Recruiting
17
IU Health North Hospital
Carmel, Indiana, United States, 46032
Actively Recruiting
18
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
19
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
20
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana, United States, 70002
Actively Recruiting
21
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
22
FMH James M Stockman Cancer Institute
Frederick, Maryland, United States, 21702
Actively Recruiting
23
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
24
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Actively Recruiting
25
Lahey Medical Center-Peabody
Peabody, Massachusetts, United States, 01960
Actively Recruiting
26
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
27
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
28
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
29
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
30
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
31
Great Falls Clinic
Great Falls, Montana, United States, 59405
Actively Recruiting
32
Hi-Line Sletten Cancer Center
Havre, Montana, United States, 59501
Actively Recruiting
33
Benefis Helena Specialty Center
Helena, Montana, United States, 59601
Actively Recruiting
34
Logan Health Medical Center
Kalispell, Montana, United States, 59901
Actively Recruiting
35
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
36
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
37
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
38
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
39
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
40
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
41
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
42
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
43
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
44
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
45
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
46
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
47
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
48
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, United States, 18519
Actively Recruiting
49
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States, 17837
Actively Recruiting
50
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
51
Fox Chase Cancer Center-Rockledge
Rockledge, Pennsylvania, United States, 19046
Actively Recruiting
52
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
53
Ralph H Johnson VA Medical Center
Charleston, South Carolina, United States, 29401
Actively Recruiting
54
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
55
Memorial Hospital of Laramie County
Cheyenne, Wyoming, United States, 82001
Actively Recruiting
56
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Actively Recruiting
Research Team
A
Aishwarya Vijendran
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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