Evaluating the impact of lymph node dissection on outcomes in high-risk bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the necessity of lymph node dissection during radical cystectomy for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who do not have enlarged lymph nodes as indicated by pelvic MRI. Participants are randomly assigned to either receive lymph node dissection along with radical cystectomy or to undergo radical cystectomy alone. The study aims to compare the incidence of complications and the progression-free survival (PFS) and overall survival (OS) rates at 1, 3, and 5 years post-surgery. The findings could help clarify the role of lymph node dissection in the treatment of NMIBC, potentially reducing unnecessary surgical interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients who did not undergo diagnostic transurethral resection of bladder tumor (TURBT): biopsy suggestive of G3/high grade or with CIS or cystoscopic findings of multiple, tumor diameter greater than 3 cm; and VI-RADS score of 1 or 2; and no enlarged lymph nodes detected by MRI.
2. Patients undergoing diagnostic TURBT: pathologically confirmed high-risk NMIBC, a) stage T1; b) G3 or high-grade; c) CIS; d) multiple, recurrent TaG1G2/low-grade bladder cancer patients with \>3 cm in diameter. And no enlarged lymph nodes detected on MRI.
3. Benefit from radical cystectomy as assessed by the investigator.
4. Meeting the indications for the procedure: a) absolute neutrophil count ≥ 1.5 \*109/L; b) platelets ≥ 100 \*109/L; c) hemoglobin ≥ 90 g/L; d) international normalized ratio or activated partial thromboplastin time ≤ 1.5 upper limit of normal (ULN); e) calculated creatinine clearance ≥ 1 ml/s f) serum total bilirubin ≤ 1.5 \* ULN; g) AST, ALT and alkaline phosphatase ≤ 2.5 \* ULN; h) cardiopulmonary function suggestive of tolerance to major abdominal surgery.
5. No previous history of tumor, lymph node dissection, or immune system-related disease.
6. Age 18 to 75 years.
7. No neoadjuvant therapy.
8. ECOG physical status 0 or 1.
9. Voluntary participation in this trial, ability to provide written informed consent, and understanding and agreement to comply with the requirements of this study and the evaluation schedule.

Exclusion Criteria:

1. Patients with bladder cancer ≥ T2N0M0 confirmed by pathology or assessed by imaging, or with pelvic lymph node enlargement indicated by MRI;
2. The investigator assessed patients who could not tolerate radical cystectomy;
3. Previous systemic chemotherapy or immunotherapy;
4. The presence of active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of large amounts of hormones and other immunosuppressants;
5. Had undergone major surgery or major trauma within 28 days before enrollment;
6. Received live vaccine within 28 days before enrollment;
7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to enrollment;
8. Received any Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days before enrollment;
9. Participating in other clinical studies.

Where it's running

• The first affiliated hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Xiao Yang, MD
• Email: yangxiao2915@163.com
• Phone: +86 13951813528

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.