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

NCT01224665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 658

Last updated 2024-11-29

Study results available
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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.

Conditions

Interventions

PROCEDURE

therapeutic conventional surgery

Patients undergo radical cystectomy

PROCEDURE

therapeutic standard lymphadenectomy

Patients undergo standard pelvic lymphadenectomy.

PROCEDURE

therapeutic extended lymphadenectomy

Patients undergo extended pelvic lymphadenectomy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Seth P. Lerner, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-25
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01224665 on ClinicalTrials.gov