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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 June 2014 by Southwest Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01224665
First received: October 19, 2010
Last updated: June 23, 2014
Last verified: June 2014

October 19, 2010
June 23, 2014
August 2011
August 2022   (final data collection date for primary outcome measure)
Disease-free progression [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01224665 on ClinicalTrials.gov Archive Site
  • Overall survival [ Designated as safety issue: No ]
  • Morbidity [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bladder Cancer
  • Procedure: therapeutic conventional surgery
    Patients undergo radical cystectomy
  • Procedure: therapeutic lymphadenectomy
    Patients undergo standard or extended pelvic lymphadenectomy.
  • Active Comparator: Arm I
    Patients undergo radical cystectomy and standard pelvic lymphadenectomy.
    Interventions:
    • Procedure: therapeutic conventional surgery
    • Procedure: therapeutic lymphadenectomy
  • Experimental: Arm II
    Patients undergo radical cystectomy and extended pelvic lymphadenectomy.
    Interventions:
    • Procedure: therapeutic conventional surgery
    • Procedure: therapeutic lymphadenectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
620
Not Provided
August 2022   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01224665
CDR0000686574, SWOG-S1011
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Seth P. Lerner, MD Baylor College of Medicine
Southwest Oncology Group
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP