A Phase III Study Comparing Standard versus Extended Pelvic Lymph Node Removal During Bladder Cancer Surgery

Protocol
12-049
Full Title
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 (SWOG S1011)
Phase
III
Purpose

During cancer surgery, lymph nodes near the tumor site are traditionally removed and analyzed to see if they contain cancer cells. The results of this analysis are used to plan subsequent therapy; patients who have lymph nodes containing cancer may receive more aggressive treatment than those with no cancer-containing lymph nodes.

In patients with bladder cancer, it has been assumed that those who have more pelvic lymph nodes removed have better survival after bladder removal surgery (cystectomy) than patients with fewer nodes removed, but this has not been examined in a formal clinical trial. The purpose of this phase III clinical trial is to compare patient outcomes after standard versus extended pelvic lymph node removal during cystectomy for bladder cancer.

Patients will be randomly assigned to have standard pelvic node removal or extended node removal, and researchers will follow them over six years to compare the outcomes of both groups. They will also compare the incidence of postoperative complications (such as lymphedema, swelling that can occur after lymph node removal) between the two groups.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have T2, T3, or T4a urothelial carcinoma of the bladder and be candidates for cystectomy.
  • Patients may not have received presurgical radiation therapy, but may have had presurgical chemotherapy. However, chemotherapy must have been completed within 70 days of the surgery, and patients must have recovered from any side effects.

For more information about this study and to inquire about eligibility, please contact Dahlia Sperling, research program coordinator, at 646-422-4387.

Disease(s)
Bladder Cancer
Locations
Related Diseases