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

A Phase III Randomized Non-inferiority Multicenter Study of PLND Omission in Clinical NMIBC Undergoing Radical Cystectomy

This study is testing whether removing lymph nodes during bladder cancer surgery helps people with high-risk non-muscle invasive bladder cancer live longer and have fewer complications compared to those who don’t have the lymph nodes removed.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05123625 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with high-risk NMIBC who have not undergone prior diagnostic transurethral resection and have no enlarged lymph nodes detected by MRI.

Not a fit: Patients with enlarged lymph nodes or those who have undergone prior treatments for bladder cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more tailored surgical approaches for high-risk NMIBC patients, minimizing unnecessary procedures and associated complications.

How similar studies have performed: While there is ongoing debate regarding lymph node dissection in NMIBC, previous studies have shown low positive rates for lymph nodes in similar patient populations, indicating that this approach may be novel and underexplored.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

• The first affiliated hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Xiao Yang, MD

Conditions: Bladder Cancer, High-risk, Lymphadenectomy, Non-muscular invasive bladder cancer