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BRIEF TITLE: 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

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


  • Org Study ID: S1011
  • Secondary ID: SWOG-S1011,NCI-2011-02604
  • NCT ID: NCT01224665
  • NCT Alias:
  • Sponsor: Southwest Oncology Group - Other
  • Source: Southwest Oncology Group

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.

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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: August 2011 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Disease-free survival

Primary Outcome 1 - Time Frame: Up to 6 years from date of Step 2 Registration

Condition:

  • Bladder Cancer

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Healthy Volunteers: No

Official Information

Name: Seth P. Lerner, MD

Role: Principal Investigator

Affiliation: Baylor College of Medicine

Overall Contact

Name: Jennifer I Scott

Phone: 210-614-8808

Email: jscott@swog.org

Locations

Facility Status Contact
Los Angeles County-USC Medical Center
Los Angeles, California 90033
United States
Recruiting Siamak Daneshmand
323-865-0451
daneshma@usc.edu
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting Siamak Daneshmand
323-865-0451
daneshma@usc.edu
Stanford Cancer Institute
Palo Alto, California 94304
United States
Recruiting Eila C. Skinner
650-498-7061
ccto-office@stanford.edu
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Suspended
UCSF Medical Center-Mount Zion
San Francisco, California 94115
United States
Recruiting Maxwell V. Meng
877-827-3222
UCSF Medical Center-Mission Bay
San Francisco, California 94158
United States
Recruiting Maxwell V. Meng
877-827-3222
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado 80045
United States
Recruiting Shandra S. Wilson
720-848-0650
Yale University
New Haven, Connecticut 06520
United States
Recruiting John W. Colberg
203-785-5702
Moffitt Cancer Center
Tampa, Florida 33612
United States
Recruiting Michael A. Poch
800-456-7121
canceranswers@moffitt.org
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
United States
Recruiting Norm D. Smith
773-834-7424
Loyola University Medical Center
Maywood, Illinois 60153
United States
Recruiting Marcus L. Quek
708-226-4357
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana 71103
United States
Suspended
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
United States
Recruiting Trinity J. Bivalacqua
410-955-8804
jhcccro@jhmi.edu
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Suspended
Mayo Clinic
Rochester, Minnesota 55905
United States
Recruiting Stephen A. Boorjian
855-776-0015
Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Recruiting Robert L. Grubb
800-600-3606
info@siteman.wustl.edu
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United States
Suspended
University of Rochester
Rochester, New York 14642
United States
Suspended
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Recruiting Andrew J. Stephenson
866-223-8100
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Recruiting Kamal S. Pohar
800-293-5066
Jamesline@osumc.edu
Oregon Health and Science University
Portland, Oregon 97239
United States
Active, not recruiting
Portland Veterans Administration Medical Center
Portland, Oregon 97239
United States
Active, not recruiting
Parkland Memorial Hospital
Dallas, Texas 75235
United States
Recruiting Arthur I. Sagalowsky
214-648-7097
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
Recruiting Arthur I. Sagalowsky
214-648-7097
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
United States
Recruiting Seth P. Lerner
713-798-1354
burton@bcm.edu
Baylor Saint Luke's Medical Center
Houston, Texas 77030
United States
Recruiting Seth P. Lerner
713-798-1354
burton@bcm.edu
M D Anderson Cancer Center
Houston, Texas 77030
United States
Suspended
Audie L Murphy Veterans Affairs Hospital
San Antonio, Texas 78209
United States
Recruiting Robert S. Svatek
210-450-3800
CTO@uthscsa.edu
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Recruiting Robert S. Svatek
210-450-3800
CTO@uthscsa.edu
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia V5Z 4E6
Canada
Recruiting Peter C. Black
888-939-3333
QEII Health Sciences Centre/Capital District Health Authority
Halifax, Nova Scotia B3H 1V8
Canada
Recruiting Ricardo A. Rendon
902-473-6000
London Regional Cancer Program
London, Ontario N6A 4L6
Canada
Recruiting Jonathan I. Izawa
519-685-8600
University Health Network-Princess Margaret Hospital
Toronto, Ontario M5G 2M9
Canada
Recruiting Girish Kulkarni
416-946-4501
clinical.trials@uhn.on.ca
McGill University Department of Oncology
Montreal, Quebec H2W 1S6
Canada
Terminated
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec H3H 2R9
Canada
Recruiting Wassim Kassouf
514-934-4400