A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive Urothelial Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 658
- Locations
- 35
- Primary Endpoint
- 5-year Disease-free Survival (DFS)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with invasive bladder cancer. It is not yet known whether extended pelvic lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery.
PURPOSE: This randomized phase II trial is studying standard pelvic lymphadenectomy to see how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing surgery for invasive bladder cancer.
Detailed Description
OBJECTIVES: Primary * To compare disease-free survival (DFS) of patients with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with extended pelvic lymph node dissection (PLND) or standard pelvic lymphadenectomy. Secondary * To compare overall survival (OS) of patients randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. * To evaluate operative time; whether or not nerve sparing was performed, intraoperative, peri-operative and 90-day morbidity and mortality; length of hospital stay; histology (pure urothelial versus mixed); lymph node counts and lymph node density; adjuvant chemotherapy received; and local and retroperitoneal soft tissue recurrence in patients randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. * To collect peripheral blood and two paraffin-embedded blocks of the primary tumor for translational medicine studies, including circulating tumor cells (CTCs) and markers of epithelial and mesenchymal transition, and correlate these findings with pathologic T stage and node metastasis as well as DFS and OS. OUTLINE: This is a multicenter study. Patients are stratified according to prior neoadjuvant therapy (yes vs no), clinical stage (T2 vs T3 vs T4a), and Zubrod performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo radical cystectomy and standard pelvic lymphadenectomy. * Arm II: Patients undergo radical cystectomy and extended pelvic lymphadenectomy. Blood and tumor specimens may be collected periodically for translational studies. After completion of study therapy, patients are followed up periodically for 6 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
5-year Disease-free Survival (DFS)
Time Frame: Duration of treatment and follow-up until death or 6 years after randomization
Comparing 5-year disease-free survival (DFS) in participants undergoing radical cystectomy for muscle-invasive urothelial carcinoma of the bladder (UCB) treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy. Disease-free survival is defined as the time from the date of randomization to date of first documentation of relapse/recurrence or death due to any cause. Participants last known to be alive without report of relapse/recurrence are censored at date of last contact. Criteria for recurrence included measurable disease on cross-sectional imaging or plain radiography targeting lung, liver, and bone. If local pelvic recurrence was identified on digital rectal examination, biopsy was required for confirmation. Second primary tumors of the upper urinary tract or retained urethra were not considered to be recurrence.
Secondary Outcomes
- 5-year Overall Survival (OS)(Duration of treatment and follow-up until death or 6 years after randomization)
- Median Operative Time(Duration of surgery)
- Median Days in Hospital(From date of operation to 90 days post-operation)
- Use of Nerve Preservation(Duration of surgery)
- Lymph Node Counts(Duration of surgery)
- Receipt of Adjuvant Chemotherapy(From date of operation to 90 days post-operation)
- Frequency of Post-Operative Local Recurrence(From date of operation to 90 days post-operation)
- Post-Operative Morbidity(From date of operation to 90 days post-operation)