S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer

Not Applicable

Completed

Conditions: Bladder Cancer

Registration Number: NCT01224665

Lead Sponsor: SWOG Cancer Research Network

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 658

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
5-year Disease-free Survival (DFS)	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 Outcome Measures

Name	Time	Method
5-year Overall Survival (OS)	Duration of treatment and follow-up until death or 6 years after randomization	Comparing 5-year overall survival (OS) in participants randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. Overall survival is defined as the time from date of randomization to date of death from any cause. Participants known to be alive are censored at date of last contact.
Median Days in Hospital	From date of operation to 90 days post-operation	Evaluating duration of post-operative hospital stay in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy.
Use of Nerve Preservation	Duration of surgery	Evaluating the frequency of nerve sparing surgery in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy.
Lymph Node Counts	Duration of surgery	Evaluating the number of positive lymph nodes removed during surgery as well as the total number of lymph nodes removed in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy.
Receipt of Adjuvant Chemotherapy	From date of operation to 90 days post-operation	Evaluating the receipt of adjuvant chemotherapy in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. Participants that reported plans to start adjuvant chemotherapy are included in these counts.
Frequency of Post-Operative Local Recurrence	From date of operation to 90 days post-operation	Evaluating the frequency of post-operative local and retroperitoneal soft-tissue recurrence in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy.
Post-Operative Morbidity	From date of operation to 90 days post-operation	Evaluating perioperative morbidity (death within 30 days of surgery) and post-operative morbidity (death within 90 days of surgery) in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy.
Median Operative Time	Duration of surgery	Evaluating duration of surgery in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy.

Trial Locations

Locations (35): Los Angeles County-USC Medical Center
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Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
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Los Angeles, California, United States
Stanford Cancer Institute
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Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center
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Sacramento, California, United States
UCSF Medical Center-Mount Zion
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San Francisco, California, United States
UCSF Medical Center-Mission Bay
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San Francisco, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
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Aurora, Colorado, United States
Yale University
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New Haven, Connecticut, United States
Moffitt Cancer Center
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Tampa, Florida, United States
University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, United States
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Los Angeles County-USC Medical Center
🇺🇸Los Angeles, California, United States