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

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Nov 9, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether removing lymph nodes during bladder cancer surgery (called radical cystectomy) helps improve patient outcomes for those with high-risk non-muscular invasive bladder cancer (NMIBC). Participants in the study are divided into two groups: one group will have their lymph nodes removed along with the bladder, while the other group will only have the bladder removed. The researchers are comparing the number of complications and how long patients live without cancer returning at 1, 3, and 5 years after surgery.

To be eligible for this trial, participants need to be between 18 and 75 years old and have been diagnosed with high-risk NMIBC, with no enlarged lymph nodes visible on an MRI. They should also be in good enough health to undergo major surgery. Participants can expect regular follow-ups to monitor their health and progress throughout the study. This trial is currently recruiting and aims to better understand the role of lymph node removal in treating bladder cancer.

Gender

ALL

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.