ClinicalTrials.gov record
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
ClinicalTrials.gov ID: NCT07000084
Public ClinicalTrials.gov record NCT07000084. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
ClinicalTrials.gov public records Last synced May 8, 2026, 12:28 AM EDT
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
GAIN-BCG: Gemcitabine Alternating With INtravesical BCG Randomized Against BCG Alone for Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer
Study identification
- NCT ID
- NCT07000084
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Other
- Enrollment
- 330 participants
Conditions and interventions
Conditions
Interventions
- BCG Solution Biological
- Biopsy of Bladder Procedure
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Cystoscopy Procedure
- Gemcitabine Drug
- Magnetic Resonance Imaging Procedure
- Transurethral Resection of Bladder Tumor Procedure
Biological · Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 16, 2025
- Primary completion
- Jun 4, 2028
- Completion
- Dec 4, 2028
- Last update posted
- Apr 6, 2026
2025 – 2028
United States locations
- U.S. sites
- 56
- U.S. states
- 20
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | Recruiting |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | Recruiting |
| Mayo Clinic Hospital in Arizona | Phoenix | Arizona | 85054 | Recruiting |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | 92612 | Recruiting |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | Recruiting |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | Recruiting |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | Recruiting |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | Recruiting |
| Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho | 83814 | Recruiting |
| Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho | 83854 | Recruiting |
| Kootenai Clinic Cancer Services - Sandpoint | Sandpoint | Idaho | 83864 | Recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Recruiting |
| University of Illinois | Chicago | Illinois | 60612 | Recruiting |
| Loyola University Medical Center | Maywood | Illinois | 60153 | Recruiting |
| Marjorie Weinberg Cancer Center at Loyola-Gottlieb | Melrose Park | Illinois | 60160 | Recruiting |
| IU Health West Hospital | Avon | Indiana | 46123 | Recruiting |
| IU Health North Hospital | Carmel | Indiana | 46032 | Recruiting |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | Recruiting |
| IU Health Methodist Hospital | Indianapolis | Indiana | 46202 | Recruiting |
| Mary Bird Perkins Cancer Center - Metairie | Metairie | Louisiana | 70002 | Recruiting |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | Recruiting |
| FMH James M Stockman Cancer Institute | Frederick | Maryland | 21702 | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Recruiting |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | Recruiting |
| Lahey Medical Center-Peabody | Peabody | Massachusetts | 01960 | Recruiting |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | Recruiting |
| Community Hospital of Anaconda | Anaconda | Montana | 59711 | Recruiting |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | Recruiting |
| Bozeman Health Deaconess Hospital | Bozeman | Montana | 59715 | Recruiting |
| Benefis Sletten Cancer Institute | Great Falls | Montana | 59405 | Recruiting |
| Great Falls Clinic | Great Falls | Montana | 59405 | Recruiting |
| Hi-Line Sletten Cancer Center | Havre | Montana | 59501 | Recruiting |
| Benefis Helena Specialty Center | Helena | Montana | 59601 | Recruiting |
| Logan Health Medical Center | Kalispell | Montana | 59901 | Recruiting |
| Community Medical Center | Missoula | Montana | 59804 | Recruiting |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Recruiting |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | Recruiting |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | Recruiting |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | Recruiting |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | Recruiting |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | Recruiting |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Recruiting |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | Recruiting |
| Geisinger Cancer Center Dickson City | Dickson City | Pennsylvania | 18519 | Recruiting |
| Geisinger Medical Oncology-Lewisburg | Lewisburg | Pennsylvania | 17837 | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | Recruiting |
| Fox Chase Cancer Center-Rockledge | Rockledge | Pennsylvania | 19046 | Recruiting |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | Recruiting |
| Ralph H Johnson VA Medical Center | Charleston | South Carolina | 29401 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| Memorial Hospital of Laramie County | Cheyenne | Wyoming | 82001 | Recruiting |
| Billings Clinic-Cody | Cody | Wyoming | 82414 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07000084, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 6, 2026 · Synced May 8, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07000084 live on ClinicalTrials.gov.