Tests skipping lymph node removal during bladder removal for high-risk non-muscle-invasive bladder cancer

Trial details

Who runs it

The First Affiliated Hospital with Nanjing Medical University

Trial code

NCT05123625

Record updated

5 August 2025

Original description

There is no consensus on the need for lymph node dissection in radical cystectomy (RC) for high-risk non-muscular invasive bladder cancer (NMIBC). Investigators divided participants at high risk of NMIBC without enlarged lymph nodes as indicated by pelvic MRI into two groups 1:1. One group of participants underwent RC combined with lymph node dissection and the other group of participants only underwent RC. The incidence of complications and PFS/OS at 1, 3, and 5 years were compared.Read full original descriptionShow less

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

There is no consensus on the need for lymph node dissection in radical cystectomy (RC) for high-risk non-muscular invasive bladder cancer (NMIBC). Investigators divided participants at high risk of NMIBC without enlarged lymph nodes as indicated by pelvic MRI into two groups 1:1. One group of participants underwent RC combined with lymph node dissection and the other group of participants only underwent RC. The incidence of complications and PFS/OS at 1, 3, and 5 years were compared.

Inclusion: 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; 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; Benefit from radical cystectomy as assessed by the investigator; 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; No previous history of tumor, lymph node dissection, or immune system-related disease; Age 18 to 75 years; No neoadjuvant therapy; ECOG physical status 0 or 1; 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: Previous systemic chemotherapy or immunotherapy; Had undergone major surgery or major trauma within 28 days before enrollment; Received live vaccine within 28 days before enrollment; Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to enrollment; Received any Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days before enrollment; Patients with bladder cancer ≥ T2N0M0 confirmed by pathology or assessed by imaging, or with pelvic lymph node enlargement indicated by MRI; The presence of active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of large amounts of hormones and other immunosuppressants; The investigator assessed patients who could not tolerate radical cystectomy; Participating in other clinical studies.

ClinicalTrials.gov NCT05123625