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

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 13-003850
  • NCT ID:

    NCT01224665
  • Sponsor Protocol Number:

    S1011

About this study

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 III 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Disease Characteristics:

  • Histologically confirmed urothelial carcinoma of the bladder
    • Stage T2, T3, or T4a disease
      • No clinical stage consistent with a low-risk of node metastasis (CIS only, T1)
      • No T4b disease (fixed lesion)
    • Disease that requires primary radical cystectomy and lymph node dissection for definitive treatment
      • No laparoscopic surgery
    • Predominant urothelial carcinoma with any of the following elements allowed:
      • Adenocarcinoma
      • Squamous cell carcinoma
      • Micropapillary or minor components of other rare phenotype
      • No pure squamous cell carcinoma or adenocarcinoma
    • No visceral or nodal metastatic disease proximal to the common iliac bifurcation by 2-view chest x-ray and abdominal-pelvic imaging by computerized tomography or MRI of the abdomen and pelvis
    • No intra-operative pelvic lymph node involvement (confirmed by frozen section) at or above the bifurcation of the common iliac vessels in any of the extended template

Patient Characteristics:

  • Zubrod performance status 0-2
  • ALT and AST ≤ upper limit of normal (ULN)*
  • Alkaline phosphatase ≤ ULN*
  • Not pregnant or nursing
  • Fertile patients must use an effective contraception
  • No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or stage I or II cancer from which the patient is in complete remission for the past 5 years
  • Medically suitable to undergo cystectomy, in the physician's opinion NOTE: *Levels may be ≥ ULN provided metastatic disease is excluded using dedicated liver imaging, bone scan, or biopsy.

Prior Concurrent Therapy:

  • See Disease Characteristics
  • No prior partial cystectomy for invasive bladder cancer
  • No prior pelvic surgery that would obviate a complete extended lymphadenectomy (e.g., aorto-femoral/iliac bypass)
  • Prior neoadjuvant chemotherapy for this cancer allowed provided it has been completed and patient has recovered
  • No prior pelvic irradiation

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Boorjian, M.D.

Closed for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015