NCT07000084Toboroz3. fázis
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: Gemcitabine Alternating With INtravesical BCG Randomized Against BCG Alone for Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 2.
Rövid összefoglaló (regiszter, angolul)
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. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 330 (tervezett)
- Első benyújtás
- 2025. máj. 23.
- Kezdés
- 2025. júl. 17.
- Elsődleges befejezés
- 2028. jún. 5.
- Fő szponzor
- Alliance for Clinical Trials in Oncology
- Betegségek
- Hólyagrák
- NCT-szám
- NCT07000084
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 330
- 2025. júl. 17. és az elsődleges befejezés (2028. jún. 5.) között
- 60 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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- 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 restaging TURBT that shows no residual cancer in the specimen are still eligible for trial based on prior TURBT
- Patients must have BCG-Exposed non muscle invasive bladder carcinoma (NMIBC), defined as recurrent high grade NMIBC within 24 months of last BCG exposure but not meeting the definition of BCG unresponsive disease
- Note: Up to 26 months from the last BCG instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence/suspicion of recurrent disease (by positive cytology, imaging, or cystoscopy) within 24 months of last exposure to BCG.
- Note: A patient who previously met the definition of BCG unresponsive NMIBC but no longer currently meets unresponsive criteria may still enroll in this trial so long as the treating urologist believes re-treatment with BCG is a reasonable treatment option for that patient.
- BCG-exposed NMIBC criteria is defined as:
- Any high grade NMIBC recurrence within 24 months of induction only BCG, or
- A high grade papillary NMIBC (Ta/T1) recurrence between 6-24 months of last exposure to induction + maintenance BCG, or
- A high-grade CIS (with or without Ta/T1 papillary disease) recurrence within 12-24 months of last exposure to induction + maintenance BCG.
- Patient must not have BCG-unresponsive NMIBC, defined as:
- Persistent or recurrent high-grade papillary NMIBC (Ta/T1) < 6 months of "adequate" BCG, or
- A high-grade CIS (with or without Ta/T1 papillary disease) recurrence < 12 months of "adequate" BCG, or
- A high grade T1 recurrence at the first 3-month assessment from induction BCG
- "Adequate" BCG is defined as ≥5 of 6 doses of induction BCG therapy with either
- ≥ 2 of 3 doses of maintenance BCG, or
- ≥ 2 of planned 6 instillations of repeat induction BCG given within a 6 month time period
- More than one prior induction course of BCG and/or prior maintenance BCG is allowed so long as the patient does not currently met the definition of BCG unresponsive disease
- Prior treatment with any intravesical chemotherapy (both perioperative and induction course) for NMIBC is allowed, including gemcitabine either alone or in combination (ie. gemcitabine plus docetaxel) or gemcitabine delivered through a intravesical delivery system (ie. TAR-200)
- Prior treatment with any systemic or intravesical agents for NMIBC is allowed, regardless of whether it is given either alone or in prior combination with BCG (ie. Prior treatment with pembrolizumab, other immune checkpoint inhibitors, nadofaragene firadenovec, nogapendekin alfa inbakicept, cretostimogene grenadenorepvec, etc. are all allowed)
- Patients must not have a history of intolerance to BCG (ie needing to stop BCG induction or maintenance due to toxicity) or intolerance to any other intravesical therapies
- Patients must not have compromised bladder function such that they are unlikely to tolerate further intravesical therapies
- Patient must not have any prior history or current evidence of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 120 days prior to randomization.
- The radiographic imaging includes a CT Scan or MRI of the abdomen/pelvis with intravenous contrast, with a CT or MRI urogram preferred. If a patient is unable to receive intravenous contrast due to renal function or allergy, then either a CT scan or MRI of the abdomen/pelvis without intravenous contrast is acceptable
- Patients with a history of upper tract urothelial carcinoma are allowed so long as they had localized non-muscle invasive (Ta, T1, Tis) that has been definitively treated with surgery (nephroureterectomy or ureterectomy) with at least one post-treatment disease assessment imaging study that demonstrates no evidence of residual upper tract disease
- Patients with a history of, or current evidence of, non-invasive (Ta/Tis) urothelial carcinoma of the prostatic urethra are eligible so long as a transurethral resection of prostate (TURP) is performed before enrollment and there is prostatic glandular tissue without evidence of lamina propria invasion or prostatic stromal invasion
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Age ≥ 18 years
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Not pregnant and not nursing, Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
- has achieved menarche at some point
- has not undergone a hysterectomy or bilateral oophorectomy
- has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (60)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Community Hospital of Anaconda | Anaconda | Egyesült Államok | Toboroz |
| IU Health West Hospital | Avon | Egyesült Államok | Toboroz |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Egyesült Államok | Toboroz |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | Egyesült Államok | Toboroz |
| Billings Clinic Cancer Center | Billings | Egyesült Államok | Toboroz |
| University of Alabama at Birmingham Cancer Center | Birmingham | Egyesült Államok | Toboroz |
| Brigham and Women's Hospital | Boston | Egyesült Államok | Toboroz |
| Bozeman Health Deaconess Hospital | Bozeman | Egyesült Államok | Toboroz |
| Roswell Park Cancer Institute | Buffalo | Egyesült Államok | Toboroz |
| Lahey Clinic | Burlington | Egyesült Államok | Toboroz |
| IU Health North Hospital | Carmel | Egyesült Államok | Toboroz |
| Medical University of South Carolina | Charleston | Egyesült Államok | Toboroz |
| Ralph H. Johnson VA Medical Center | Charleston | Egyesült Államok | Toboroz |
| Memorial Hospital of Laramie County | Cheyenne | Egyesült Államok | Toboroz |
| University of Illinois | Chicago | Egyesült Államok | Toboroz |
| Northwestern University | Chicago | Egyesült Államok | Toboroz |
| Billings Clinic-Cody | Cody | Egyesült Államok | Toboroz |
| Kootenai Health - Coeur d'Alene | Coeur d'Alene | Egyesült Államok | Toboroz |
| Ohio State University Comprehensive Cancer Center | Columbus | Egyesült Államok | Toboroz |
| Memorial Sloan Kettering Commack | Commack | Egyesült Államok | Toboroz |
| Geisinger Medical Center | Danville | Egyesült Államok | Toboroz |
| Geisinger Cancer Center Dickson City | Dickson City | Egyesült Államok | Toboroz |
| Fairbanks Memorial Hospital | Fairbanks | Egyesült Államok | Toboroz |
| FMH James M Stockman Cancer Institute | Frederick | Egyesült Államok | Toboroz |
| UF Health Cancer Institute - Gainesville | Gainesville | Egyesült Államok | Toboroz |
| Banner MD Anderson Cancer Center | Gilbert | Egyesült Államok | Toboroz |
| Benefis Sletten Cancer Institute | Great Falls | Egyesült Államok | Toboroz |
| Great Falls Clinic | Great Falls | Egyesült Államok | Toboroz |
| Hackensack University Medical Center | Hackensack | Egyesült Államok | Toboroz |
| Memorial Sloan Kettering Westchester | Harrison | Egyesült Államok | Toboroz |
| Hi-Line Sletten Cancer Center | Havre | Egyesült Államok | Toboroz |
| Benefis Helena Specialty Center | Helena | Egyesült Államok | Toboroz |
| IU Health Methodist Hospital | Indianapolis | Egyesült Államok | Toboroz |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Egyesült Államok | Toboroz |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | Egyesült Államok | Toboroz |
| Mayo Clinic in Florida | Jacksonville | Egyesült Államok | Toboroz |
| Logan Health Medical Center | Kalispell | Egyesült Államok | Toboroz |
| Geisinger Medical Oncology-Lewisburg | Lewisburg | Egyesült Államok | Toboroz |
| Loyola University Medical Center | Maywood | Egyesült Államok | Toboroz |
| Marjorie Weinberg Cancer Center at Loyola-Gottlieb | Melrose Park | Egyesült Államok | Toboroz |
| Mary Bird Perkins Cancer Center - Metairie | Metairie | Egyesült Államok | Toboroz |
| Memorial Sloan Kettering Monmouth | Middletown | Egyesült Államok | Toboroz |
| Community Medical Center | Missoula | Egyesült Államok | Toboroz |
| Memorial Sloan Kettering Bergen | Montvale | Egyesült Államok | Toboroz |
| Veterans Affairs New York Harbor Healthcare System-Manhattan Campus | New York | Egyesült Államok | Toboroz |
| Memorial Sloan-Kettering Cancer Center | New York | Egyesült Államok | Toboroz |
| University of Oklahoma Health Sciences Center | Oklahoma City | Egyesült Államok | Toboroz |
| UC Irvine Health- Chao Family Comprehensive Cancer Center | Orange | Egyesült Államok | Toboroz |
| Lahey Clinic Peabody | Peabody | Egyesült Államok | Toboroz |
| Fox Chase Cancer Center | Philadelphia | Egyesült Államok | Toboroz |
| Mayo Clinic Hospital in Arizona | Phoenix | Egyesült Államok | Toboroz |
| Kootenai Clinic Cancer Services - Post Falls | Post Falls | Egyesült Államok | Toboroz |
| Renown Regional Medical Center | Reno | Egyesült Államok | Toboroz |
| VCU Massey Comprehensive Cancer Center | Richmond | Egyesült Államok | Toboroz |
| Mayo Clinic in Rochester | Rochester | Egyesült Államok | Toboroz |
| Fox Chase Cancer Center-Rockledge | Rockledge | Egyesült Államok | Toboroz |
| Kootenai Clinic Cancer Services - Sandpoint | Sandpoint | Egyesült Államok | Toboroz |
| Memorial Sloan Kettering Nassau | Uniondale | Egyesült Államok | Toboroz |
| Sibley Memorial Hospital | Washington D.C. | Egyesült Államok | Toboroz |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Egyesült Államok | Toboroz |
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