Back to resultsS1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
therapeutic conventional surgery
therapeutic standard lymphadenectomy
therapeutic extended lymphadenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring stage II bladder cancer, stage III bladder cancer, transitional cell carcinoma of the bladder
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
Sites / Locations
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Stanford Cancer Institute
- University of California Davis Comprehensive Cancer Center
- UCSF Medical Center-Mount Zion
- UCSF Medical Center-Mission Bay
- University of Colorado Cancer Center - Anschutz Cancer Pavilion
- Yale University
- Moffitt Cancer Center
- University of Chicago Comprehensive Cancer Center
- Loyola University Medical Center
- Louisiana State University Health Sciences Center Shreveport
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Brigham and Women's Hospital
- Mayo Clinic
- Washington University School of Medicine
- Memorial Sloan-Kettering Cancer Center
- University of Rochester
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Oregon Health and Science University
- Portland Veterans Administration Medical Center
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Baylor Saint Luke's Medical Center
- M D Anderson Cancer Center
- Audie L Murphy Veterans Affairs Hospital
- University of Texas Health Science Center at San Antonio
- BCCA-Vancouver Cancer Centre
- QEII Health Sciences Centre/Capital District Health Authority
- London Regional Cancer Program
- University Health Network-Princess Margaret Hospital
- McGill University Department of Oncology
- The Research Institute of the McGill University Health Centre (MUHC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm I
Arm II
Arm Description
therapeutic conventional surgery therapeutic standard lymphadenectomy
therapeutic conventional surgery therapeutic extended lymphadenectomy
Outcomes
Primary Outcome Measures
Disease-free survival
Secondary Outcome Measures
Overall survival
Morbidity
Full Information
NCT ID
NCT01224665
First Posted
October 19, 2010
Last Updated
May 1, 2023
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01224665
Brief Title
S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 25, 2011 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage II bladder cancer, stage III bladder cancer, transitional cell carcinoma of the bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
658 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
therapeutic conventional surgery therapeutic standard lymphadenectomy
Arm Title
Arm II
Arm Type
Experimental
Arm Description
therapeutic conventional surgery therapeutic extended lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Patients undergo radical cystectomy
Intervention Type
Procedure
Intervention Name(s)
therapeutic standard lymphadenectomy
Intervention Description
Patients undergo standard pelvic lymphadenectomy.
Intervention Type
Procedure
Intervention Name(s)
therapeutic extended lymphadenectomy
Intervention Description
Patients undergo extended pelvic lymphadenectomy
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
Up to 6 years from date of Step 2 Registration
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
Up to 6 years from date of Step 2 Registration
Title
Morbidity
Time Frame
Up to 6 years from date of Step 2 Registration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth P. Lerner, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles County-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Stanford Cancer Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSF Medical Center-Mount Zion
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
UCSF Medical Center-Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University of Colorado Cancer Center - Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Louisiana State University Health Sciences Center Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Portland Veterans Administration Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Saint Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Audie L Murphy Veterans Affairs Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
BCCA-Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
QEII Health Sciences Centre/Capital District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V8
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
University Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University Department of Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
The Research Institute of the McGill University Health Centre (MUHC)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 2R9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
27345655
Citation
Kamat AM, Hahn NM, Efstathiou JA, Lerner SP, Malmstrom PU, Choi W, Guo CC, Lotan Y, Kassouf W. Bladder cancer. Lancet. 2016 Dec 3;388(10061):2796-2810. doi: 10.1016/S0140-6736(16)30512-8. Epub 2016 Jun 23. Erratum In: Lancet. 2016 Dec 3;388(10061):2742.
Results Reference
derived
PubMed Identifier
25150172
Citation
Froehner M, Novotny V, Heberling U, Rutsch L, Litz RJ, Hubler M, Koch R, Baretton GB, Wirth MP. Relationship of the number of removed lymph nodes to bladder cancer and competing mortality after radical cystectomy. Eur Urol. 2014 Dec;66(6):987-90. doi: 10.1016/j.eururo.2014.07.046. Epub 2014 Aug 19.
Results Reference
derived
Learn more about this trial
S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
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