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

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ClinicalTrials.gov Identifier: NCT01224665
Recruitment Status : Active, not recruiting
First Posted : October 20, 2010
Last Update Posted : May 3, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
SWOG Cancer Research Network

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Bladder Cancer Procedure: therapeutic conventional surgery Procedure: therapeutic standard lymphadenectomy Procedure: therapeutic extended lymphadenectomy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 658 participants
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
Actual Study Start Date : November 25, 2011
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224665


Locations
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Sponsors and Collaborators
SWOG Cancer Research Network
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Seth P. Lerner, MD Baylor College of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: SWOG Cancer Research Network
ClinicalTrials.gov Identifier: NCT01224665    
Other Study ID Numbers: S1011
SWOG-S1011 ( Other Grant/Funding Number: U10CA180888 )
NCI-2011-02604 ( Registry Identifier: NCI )
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
Keywords provided by SWOG Cancer Research Network:
stage II bladder cancer
stage III bladder cancer
transitional cell carcinoma of the bladder
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases