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Taking people in United StatesPhase 2

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.

Key facts

Who runs it
Rutgers, The State University of New Jersey
Where
New Brunswick, United StatesSee the site
Trial code
Registry title
Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
Status
Recruiting
Phase
Phase 2
People taking part
60 people, planned
Started
10 Jul 2026
Expected to end
Jul 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Neoadjuvant Therapy
  • Upfront radical cystectomy
Record updated
13 August 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • ▪ 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in United States

  • Rutgers Cancer InstituteNew Brunswick, United StatesContact: Saum Ghodoussipour, MDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Neoadjuvant Systemic Therapy Followed by Radical CystectomyExisting treatment, for comparison

    Participants receive standard-of-care neoadjuvant systemic therapy, as selected by the treating physician, followed by radical cystectomy with urinary diversion. Interventions: Each specific drug regimen confirmed by the PI, plus Radical Cystectomy With Urinary Diversion.

    Treatment: Neoadjuvant Therapy and Upfront radical cystectomy

  • Upfront Radical CystectomyTreatment being tested

    Participants proceed directly to radical cystectomy with urinary diversion without receiving initial neoadjuvant systemic therapy. Intervention: Radical Cystectomy With Urinary Diversion

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
Plain-language title
Treatment Before Surgery Versus Surgery Alone for Luminal Muscle-Invasive Bladder CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07762586, who can take part
Record updated
13 August 2026