Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorRutgers, The State University of New Jersey

About this trial

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.

Eligibility criteria

Qualifiers

▪ Inclusion Criteria

Willing and able to provide informed consent

Age ≥18 years old

Eligible to receive standard of care systemic neoadjuvant therapy

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Neoadjuvant Therapy
  • Upfront radical cystectomy

Treatment groups

60 Participants
are divided into 2 treatment groups