NCT07762586 · Rutgers, The State University of New Jersey
Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
What this study is about
This study is a two-treatment group$1 phase II randomly assigned trial investigating patients with luminal subtype muscle-invasive bladder cancer (MIBC) receiving neoadjuvant therapy (NAT) followed by cystectomy compared to those receiving upfront cystectomy.
View original scientific description
This study is a two-arm phase II randomized trial investigating patients with luminal subtype muscle-invasive bladder cancer (MIBC) receiving neoadjuvant therapy (NAT) followed by cystectomy compared to those receiving upfront cystectomy.
Interventions
DRUG
Neoadjuvant Therapy
Patients will undergo standard of care neoadjuvant therapy followed by radical cystectomy
PROCEDURE
Upfront radical cystectomy
Patients will undergo upfront radical cystectomy without neoadjuvant therapy
Primary outcome measures
: Pathological upstaging rate at radical cystectomy (pT3-pT4 or pN+)
Time frame: At the time of radical cystectomy
Percentage of evaluable participants in each study arm who are pathologically upstaged from clinical stage cT2N0 disease to pathological stage pT3-pT4 or pN+ disease, based on examination of the radical cystectomy specimen.
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
- ▪ Inclusion Criteria
- Willing and able to provide informed consent
- Age ≥18 years old
- Eligible to receive standard of care systemic neoadjuvant therapy
- Eastern Cooperative Group (ECOG) performance status of 0-1
- Documented histologically confirmed urothelial muscle-invasive bladder cancer
- cT2N0M0 bladder cancer based on pre-TURBT bimanual exam and cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT.
- Willing to undergo RC with urinary diversion
- No signs of extravesical disease on pre-TURBT conventional imaging
- Variant histology is allowed so long as the tumor is predominantly urothelial carcinoma.
- No presence of LVI on TURBT
- Decipher Bladder GSC test result
- Ineligible for or refusing TMT
- The population is adult men or women of any ethnicity diagnosed with muscle-invasive bladder cancer.
Exclusion criteria
- Patients under 18 years old. Considering the minimal incidence of bladder cancer among the pediatric population, children are not eligible for this study.
- Not willing or unable to give informed consent.
- Clinical or pathological evidence of metastatic disease, including, non-regional lymph nodes, visceral lesions, and bone lesions.
- Significant hepatic impairment (Serum bilirubin \> 1.5x upper limit of normal).
- Significant renal impairment (creatinine clearance \<30 ml/min).
- Predominant variant histology (i.e. nested, micropapillary, sarcomatoid, plasmacytoid, small cell)6
- cT3 bladder cancer on pre-TURBT bimanual exam or with hydronephrosis on cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT
- TURBT specimen with lymphovascular invasion (LVI) cT4 or unresectable bladder cancer
- Concurrent diagnoses of other, non-urothelial, malignancies or prior malignancy diagnoses within the past three years. Exceptions, determined at the discretion of the principal investigator, include squamous cell carcinoma, basal cell carcinoma, or other low-grade cancer not expected to progress or require surgical/systemic therapy.
- Prior history of systemic treatment for non-urothelial malignancies in the past three years, including chemotherapy and immunotherapy.
- Prior diagnosis or evidence of psychiatric or medical conditions that may prevent patients from giving full and properly informed consent.
- Any medical, familial, psychiatric, or geographic considerations that may prevent patients from study participation or follow-up required by the study protocol
- Patients (cN+) are excluded from participation and are not eligible for enrollment.
- Prisoners, Individuals without Decisional Capacity, and Pregnant Women will be excluded.
Where
- New Brunswick, New Jersey
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 Aug 13, 2026 · Source of record for eligibility and locations