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ACTIVE NOT RECRUITING

NCT05538663

PHASE3

Intravesical BCG vs GEMDOCE in NMIBC

Sponsor: ECOG-ACRIN Cancer Research Group

View on ClinicalTrials.gov

Summary

The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the usual BCG therapy approach. The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.

Official title: A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

870

Start Date

2023-02-07

Completion Date

2030-10

Last Updated

2026-09-15

Healthy Volunteers

Conditions

Non-muscle-invasive Bladder Cancer

Interventions

DRUG

Gemcitabine

Intravesical once a week for 6 consecutive weeks followed by monthly instillations during maintenance for 2 years

DRUG

Docetaxel

Intravesical once a week for 6 consecutive weeks followed by monthly instillations during maintenance for 2 years

DRUG

Bacillus Calmette Guerin

intravesical once a week for 6 consecutive weeks during induction followed by weekly instillations for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 months

Inclusion Criteria: * Patient must be \> 18 years of age. * Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage) on transurethral resection of bladder tumor (TURBT) obtained within 90 days prior to randomization. * Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization. If the treating urologist did not perform the TURBT as outlined in Section 3.1.3, the treating urologist must perform a cystoscopy within 28 days prior to randomization to confirm the absence of visible papillary disease. * Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT. * Patients with high grade T1 disease must have undergone a restaging TURBT within 90 days prior to Step 1 randomization. NOTE: Patients with high grade T1 disease who undergo a restaging TURBT that shows no residual cancer in the restaging TURBT specimen are eligible. * Patient must not have pure squamous cell carcinoma or adenocarcinoma. * Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell). * Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology. * 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. * Patient must have ECOG Performance Status 0-2. * Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy. * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible. * Patient must have adequate organ and marrow function as defined below (these labs must be obtained ≤ 28 days prior to randomization): Leukocytes ≥ 3,000/mcL Leukocytes:\_\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_\_\_\_ Absolute neutrophil count (ANC) ≥ 1,500/mcL ANC:\_\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_\_\_\_ Platelets ≥ 70,000/mcL Platelets:\_\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_\_\_\_ Total Bilirubin ≤ institutional upper limit of normal (ULN) Total Bilirubin:\_\_\_\_\_\_\_\_\_\_ Institutional ULN:\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_\_\_\_ AST(SGOT)/ALT(SGPT) ≤ 3.0 × institutional ULN AST:\_\_\_\_\_\_\_ Institutional ULN:\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_ ALT: \_\_\_\_\_\_\_Institutional ULN:\_\_\_\_\_\_\_\_\_ * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Exclusion Criteria: * Patient must not have any prior or current history of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 90 days prior to randomization. The radiographic imaging includes a CT Scan OR MRI of the abdomen/pelvis with intravenous contrast. NOTE: If a patient's renal function does not permit the administration of intravenous contrast, either a CT scan or MRI of the abdomen/pelvis without intravenous contrast is acceptable. NOTE: Patients with a history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e., either cytology, biopsy, or imaging) that demonstrates no evidence of residual disease are eligible. \- 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: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) 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). Patient of child bearing potential? \_\_\_\_\_\_ (Yes or No) Date of blood test or urine study: \_\_\_\_\_\_\_\_\_\_\_ * Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. In addition,patients on Arm A must continue contraception measures for six months after the last dose of GEMDOCE for patients of child-bearing potential and continue for three month after the last dose of GEMDOC for male patients with partners of child-bearing potential. All patients must not breastfeed during their time on protocol treatment. * Patient must not have a history of severe hypersensitivity reactions to docetaxel or drugs formulated with polysorbate 80.

Locations (229)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

CARTI Cancer Center

Little Rock, Arkansas, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Mercy Cancer Center

Merced, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

BASS Medical Group - Lennon

Walnut Creek, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

The Women's Imaging Center