Home › Bladder Cancer › NCT07762586
Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
RecruitingPhase 2
Who can join
Ages 18 to 90 · All sexes
Full eligibility criteria
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 * No cN+ * 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.
About the study
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.
What is being tested
- Neoadjuvant Therapy (drug)
- Upfront radical cystectomy (procedure)
Sponsor: Rutgers, The State University of New Jersey · Participants: 60 · Started: Jul 10, 2026
Contact the study team
- Saum Ghodoussipour, MD · Phone: 732-235-2465
Official record on ClinicalTrials.gov — NCT07762586
Locations in the U.S.
| New Jersey | Rutgers Cancer Institute, New Brunswick |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.