Clinical trial · Interventional
Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
NCT07762586CI-TRIAL-00121837recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant Therapy | Drug | — | UNRESOLVED |
| Upfront radical cystectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant Systemic Therapy Followed by Radical Cystectomy
- description
- 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.
- interventionNames
- Drug: Neoadjuvant Therapy
- Procedure: Upfront radical cystectomy
- type
- EXPERIMENTAL
- label
- Upfront Radical Cystectomy
- description
- Participants proceed directly to radical cystectomy with urinary diversion without receiving initial neoadjuvant systemic therapy. Intervention: Radical Cystectomy With Urinary Diversion
- interventionNames
- Procedure: Upfront radical cystectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.