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 July 2016 by Southwest Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01224665
First received: October 19, 2010
Last updated: July 21, 2016
Last verified: July 2016
  Purpose

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 Phase
Bladder Cancer
Procedure: therapeutic conventional surgery
Procedure: therapeutic lymphadenectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 6 years from date of Step 2 Registration ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: Up to 6 years from date of Step 2 Registration ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01224665

Contacts
Contact: Jennifer I Scott 210-614-8808 ext 1007 jscott@swog.org
Contact: Dana B Sparks, M.A.T. 210-614-8808 ext 1004 dsparks@swog.org

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01224665     History of Changes
Other Study ID Numbers: S1011  SWOG-S1011  NCI-2011-02604 
Study First Received: October 19, 2010
Last Updated: July 21, 2016
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

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
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2016