Study on Neoadjuvant Chemotherapy for Luminal Bladder Cancer (LUMBER-NAC)

Sponsor: Rutgers, The State University of New Jersey

Sponsor score: 40

ClinicalTrials ID:NCT07762586

Provider View

This clinical trial is comparing two treatment approaches for patients with muscle-invasive bladder cancer: receiving chemotherapy before surgery or having surgery first. The study aims to determine which method is safer and more effective for patients with the luminal subtype of this cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if starting with chemotherapy before surgery (neoadjuvant therapy) is better than going straight to surgery for patients with muscle-invasive bladder cancer (MIBC) of the luminal subtype. Researchers will use a test called GSC-Decipher Bladder to analyze the cancer's genetic subtype and will also monitor tumor DNA in the blood. The study will compare the outcomes of patients who receive chemotherapy before surgery with those who have surgery first, focusing on safety and effectiveness.

Description

This study is exploring two treatment options for patients with muscle-invasive bladder cancer (MIBC) of the luminal subtype. The standard approach is to give chemotherapy before surgery, which can include cisplatin-based chemotherapy or new combinations of chemotherapy and immunotherapy. This approach aims to improve survival, but not all patients benefit equally, and some may experience side effects.

In this trial, researchers will use a test called GSC-Decipher Bladder to determine the genetic subtype of the cancer (luminal or basal). They will also check for tumor DNA in the blood at different times to see how the cancer responds to treatment. The study will compare patients who receive chemotherapy before surgery with those who have surgery first, looking at how safe and effective each approach is.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to provide informed consent.
  • Eligible for standard chemotherapy before surgery.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Diagnosed with muscle-invasive bladder cancer confirmed by tests.
  • Cancer stage cT2N0M0 based on exams and imaging done within 8 weeks before surgery or starting chemotherapy.
  • Willing to have surgery to remove the bladder and create a new way to store urine.
  • No signs of cancer outside the bladder on imaging tests.
  • Tumor is mainly urothelial carcinoma, even if there are other types of cancer cells present.
  • No lymphovascular invasion (LVI) in the tumor sample.
  • Have results from the Decipher Bladder GSC test.
  • Not eligible for or refusing trimodality therapy (TMT).
  • No cancer spread to lymph nodes (cN+).
  • Open to adult men and women of any ethnicity with muscle-invasive bladder cancer.

Exclusion Criteria

  • Under 18 years old.
  • Unable or unwilling to provide informed consent.
  • Evidence of cancer spread to other parts of the body, like lymph nodes, organs, or bones.
  • Severe liver problems (high bilirubin levels).
  • Severe kidney problems (low creatinine clearance).
  • Tumor is mainly a different type of cancer (e.g., small cell, sarcomatoid).
  • Cancer stage cT3 or with kidney swelling on imaging before surgery or chemotherapy.
  • Tumor sample shows lymphovascular invasion or is too advanced to remove.
  • Other cancers diagnosed within the last three years, except for certain low-risk types.
  • Previous treatment for other cancers in the last three years.
  • Medical or psychiatric conditions that prevent informed consent.
  • Any issues that prevent participation or follow-up in the study.
  • Cancer spread to lymph nodes (cN+).
  • Prisoners, individuals unable to make decisions, and pregnant women are excluded.

Locations

FACILITYZIPCITYSTATE
Rutgers Cancer Institute08901New BrunswickNew Jersey

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