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Trial record 1 of 1 for:    NCT01224665
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S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group Identifier:
First received: October 19, 2010
Last updated: April 20, 2017
Last verified: April 2017

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.

Condition Intervention
Bladder Cancer Procedure: therapeutic conventional surgery Procedure: therapeutic standard lymphadenectomy Procedure: therapeutic extended lymphadenectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: Up to 6 years from date of Step 2 Registration ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 6 years from date of Step 2 Registration ]
  • Morbidity [ Time Frame: Up to 6 years from date of Step 2 Registration ]

Estimated Enrollment: 620
Study Start Date: August 2011
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
therapeutic conventional surgery therapeutic standard lymphadenectomy
Procedure: therapeutic conventional surgery
Patients undergo radical cystectomy
Procedure: therapeutic standard lymphadenectomy
Patients undergo standard pelvic lymphadenectomy.
Experimental: Arm II
therapeutic conventional surgery therapeutic extended lymphadenectomy
Procedure: therapeutic conventional surgery
Patients undergo radical cystectomy
Procedure: therapeutic extended lymphadenectomy
Patients undergo extended pelvic lymphadenectomy

Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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.


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01224665

Contact: Jennifer I Scott 210-614-8808 ext 1007
Contact: Dana B Sparks, M.A.T. 210-614-8808 ext 1004

  Show 35 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Seth P. Lerner, MD Baylor College of Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Southwest Oncology Group Identifier: NCT01224665     History of Changes
Other Study ID Numbers: S1011
SWOG-S1011 ( Other Grant/Funding Number: U10CA180888 )
NCI-2011-02604 ( Registry Identifier: NCI )
Study First Received: October 19, 2010
Last Updated: April 20, 2017

Keywords provided by Southwest Oncology Group:
stage II bladder cancer
stage III bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases processed this record on September 20, 2017