Prognostic Effect of Whether Doing PLND During RC for High-risk NMIBC

NCT05123625 | Recruiting

• 1 other identifier: 2021-SR-291.A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

High-risk; Lymphadenectomy; Non-muscular invasive bladder cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  5 years after surgery

Secondary Outcomes (1)

• OS

  5 years after surgery

Other Outcomes (1)

• Complication rate

  through study completion, an average of 1 year

Study Arms (2)

RC combined with lymph node dissection

NO INTERVENTION

When radical cystectomy was performed, pelvic lymph node dissection was also performed.

Only RC

EXPERIMENTAL

In the intervention group, investigators used a reductive approach. That is, for radical cystectomy, investigators did not perform pelvic lymph node dissection.

Procedure: Reduce surgical procedures

Interventions

Reduce surgical procedures PROCEDURE

In the intervention group, investigators used a reductive approach. That is, for radical cystectomy, investigators did not perform pelvic lymph node dissection.

Only RC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with bladder cancer ≥ T2N0M0 confirmed by pathology or assessed by imaging, or with pelvic lymph node enlargement indicated by MRI;
• The investigator assessed patients who could not tolerate radical cystectomy;
• Previous systemic chemotherapy or immunotherapy;
• The presence of active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of large amounts of hormones and other immunosuppressants;
• 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;
• Participating in other clinical studies.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• The Second Affiliated Hospital of Kunming Medical University: collaborator
• Tianjin Medical University Second Hospital: collaborator
• RenJi Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator

Study Sites (1)

The first affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

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MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Qiang Lu, PhD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Xiao Yang, MD

CONTACT

+86 13951813528; yangxiao2915@163.com

Juntao Zhuang

CONTACT

+86 15651753950; doctorlvqiang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: November 17, 2021
• Study Start: July 1, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)