Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
Rutgers, The State University of New Jersey
Summary
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.
Description
The goal of this study is to assess the feasibility and oncologic safety of upfront radical cystectomy in luminal MIBC, using pathological upstaging (pT3-4 or pN+) and efficacy as the primary safety endpoints. For patients with muscle-invasive bladder cancer (MIBC), the standard treatment remains sequential neoadjuvant therapy (NAT), which may include either cisplatin-based chemotherapy or novel approved combination regimens (i.e., chemotherapy and immunotherapy) followed by cystectomy. Although NAT improves overall survival, individual patient responses are heterogeneous (meaning not all pat…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
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 *…
Interventions
- DrugNeoadjuvant Therapy
Patients will undergo standard of care neoadjuvant therapy followed by radical cystectomy
- ProcedureUpfront radical cystectomy
Patients will undergo upfront radical cystectomy without neoadjuvant therapy
Location
- Rutgers Cancer InstituteNew Brunswick, New Jersey