Clincosm LogoSign in Get a demo

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

Sponsor
Southwest Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01224665
Collaborator
National Cancer Institute (NCI) (NIH)
658
Enrollment
35
Locations
2
Arms
148
Anticipated Duration (Months)
18.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: therapeutic conventional surgery
  • Procedure: therapeutic standard lymphadenectomy
  • Procedure: therapeutic extended lymphadenectomy
 N/A

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

Study Type:
Interventional
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 :
Aug 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Disease-free survival [Up to 6 years from date of Step 2 Registration]

Secondary Outcome Measures

  1. Overall survival [Up to 6 years from date of Step 2 Registration]

  2. Morbidity [Up to 6 years from date of Step 2 Registration]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Los Angeles County-USC Medical Center Los Angeles California United States 90033
2 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
3 Stanford Cancer Institute Palo Alto California United States 94304
4 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
5 UCSF Medical Center-Mount Zion San Francisco California United States 94115
6 UCSF Medical Center-Mission Bay San Francisco California United States 94158
7 University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora Colorado United States 80045
8 Yale University New Haven Connecticut United States 06520
9 Moffitt Cancer Center Tampa Florida United States 33612
10 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
11 Loyola University Medical Center Maywood Illinois United States 60153
12 Louisiana State University Health Sciences Center Shreveport Shreveport Louisiana United States 71103
13 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
14 Brigham and Women's Hospital Boston Massachusetts United States 02115
15 Mayo Clinic Rochester Minnesota United States 55905
16 Washington University School of Medicine Saint Louis Missouri United States 63110
17 Memorial Sloan-Kettering Cancer Center New York New York United States 10065
18 University of Rochester Rochester New York United States 14642
19 Cleveland Clinic Foundation Cleveland Ohio United States 44195
20 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
21 Oregon Health and Science University Portland Oregon United States 97239
22 Portland Veterans Administration Medical Center Portland Oregon United States 97239
23 Parkland Memorial Hospital Dallas Texas United States 75235
24 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
25 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
26 Baylor Saint Luke's Medical Center Houston Texas United States 77030
27 M D Anderson Cancer Center Houston Texas United States 77030
28 Audie L Murphy Veterans Affairs Hospital San Antonio Texas United States 78209
29 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
30 BCCA-Vancouver Cancer Centre Vancouver British Columbia Canada V5Z 4E6
31 QEII Health Sciences Centre/Capital District Health Authority Halifax Nova Scotia Canada B3H 1V8
32 London Regional Cancer Program London Ontario Canada N6A 4L6
33 University Health Network-Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
34 McGill University Department of Oncology Montreal Quebec Canada H2W 1S6
35 The Research Institute of the McGill University Health Centre (MUHC) Montreal Quebec Canada H3H 2R9

Sponsors and Collaborators

  • Southwest Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Seth P. Lerner, MD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01224665
Other Study ID Numbers:
  • S1011
  • SWOG-S1011
  • NCI-2011-02604
First Posted:
Oct 20, 2010
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
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

Study Results

No Results Posted as of Jul 22, 2022