Treatment Before Surgery Versus Surgery Alone for Luminal Muscle-Invasive Bladder Cancer
Compares drug treatment before bladder removal with surgery alone in luminal bladder cancer.
Plain-language title generated from the registry record
Registry title: Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
Key facts
- Where
- New Brunswick, United StatesSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with muscle-invasive bladder cancer of the luminal subtype that has not spread. It compares treatment before surgery followed by bladder removal with bladder removal right away.
- Age
- 18 to 90 years
- Sex
- Men and women can join.
- Disease stage
- Urothelial muscle-invasive bladder cancer, stage cT2N0M0, with no signs of disease outside the bladder and no lymphovascular invasion on TURBT. Mostly urothelial cancer cells (variant histology allowed if predominantly urothelial).
- Earlier treatment
- Must be able to receive standard systemic treatment before surgery and be willing to have radical cystectomy (bladder removal) with urinary diversion. Must be ineligible for or refuse TMT. No systemic treatment for other cancers in the past three years.
- Biomarker or test result
- A Decipher Bladder GSC test result is needed.
Main reasons for not taking part
- Cancer that has spread to other parts of the body or to lymph nodes (cN+)
- Cancer at stage cT3 or cT4, or unresectable
- Predominant variant histology such as nested, micropapillary, sarcomatoid, plasmacytoid or small cell
- Serious liver problems or creatinine clearance below 30 ml/min
- Other non-urothelial cancer, or another cancer in the past three years
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT07762586, who can take part
Where in United States
- Rutgers Cancer InstituteNew Brunswick, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rutgers, The State University of New Jersey
- Trial code
- NCT07762586
- Record updated
- 13 August 2026
- Original 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.Read full original descriptionShow less
Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
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.
Inclusion: ▪ 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: 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; Clinical or pathological evidence of metastatic disease, including, non-regional lymph nodes, visceral lesions, and bone lesions; 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; Any medical, familial, psychiatric, or geographic considerations that may prevent patients from study participation or follow-up required by the study protocol; Significant hepatic impairment (Serum bilirubin > 1.5x upper limit of normal); Significant renal impairment (creatinine clearance <30 ml/min); 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; Predominant variant histology (i.e. nested, micropapillary, sarcomatoid, plasmacytoid, small cell)6; Patients (cN+) are excluded from participation and are not eligible for enrollment; Prisoners, Individuals without Decisional Capacity, and Pregnant Women will be excluded.