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

NCT01224665 | Completed Results DMC

• 3 other identifiers: S1011SWOG-S1011NCI-2011-02604
• Study Type: interventional
• Target: 658
• Locations: 2 countries
• Sites: 35

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.

Conditions

Bladder Cancer

Keywords

stage II bladder cancer; stage III bladder cancer; transitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (1)

• 5-year Disease-free Survival (DFS)

  Comparing 5-year disease-free survival (DFS) in participants undergoing radical cystectomy for muscle-invasive urothelial carcinoma of the bladder (UCB) treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy. Disease-free survival is defined as the time from the date of randomization to date of first documentation of relapse/recurrence or death due to any cause. Participants last known to be alive without report of relapse/recurrence are censored at date of last contact. Criteria for recurrence included measurable disease on cross-sectional imaging or plain radiography targeting lung, liver, and bone. If local pelvic recurrence was identified on digital rectal examination, biopsy was required for confirmation. Second primary tumors of the upper urinary tract or retained urethra were not considered to be recurrence.

  Duration of treatment and follow-up until death or 6 years after randomization

Secondary Outcomes (8)

• 5-year Overall Survival (OS)

  Duration of treatment and follow-up until death or 6 years after randomization

• Median Operative Time

  Duration of surgery

• Median Days in Hospital

  From date of operation to 90 days post-operation

• Use of Nerve Preservation

  Duration of surgery

• Lymph Node Counts

  Duration of surgery

Study Arms (2)

Arm I

ACTIVE COMPARATOR

therapeutic conventional surgery therapeutic standard lymphadenectomy

Procedure: therapeutic conventional surgery; Procedure: therapeutic standard lymphadenectomy

Arm II

EXPERIMENTAL

therapeutic conventional surgery therapeutic extended lymphadenectomy

Procedure: therapeutic conventional surgery; Procedure: therapeutic extended lymphadenectomy

Interventions

therapeutic conventional surgery PROCEDURE

Patients undergo radical cystectomy

Arm I; Arm II

therapeutic standard lymphadenectomy PROCEDURE

Patients undergo standard pelvic lymphadenectomy.

Arm I

therapeutic extended lymphadenectomy PROCEDURE

Patients undergo extended pelvic lymphadenectomy

Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (35)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Stanford Cancer Institute

Palo Alto, California, 94304, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States

Location

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Louisiana State University Health Sciences Center Shreveport

Shreveport, Louisiana, 71103, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Portland Veterans Administration Medical Center

Portland, Oregon, 97239, United States

Location

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

Location

Baylor Saint Luke's Medical Center

Houston, Texas, 77030, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Audie L Murphy Veterans Affairs Hospital

San Antonio, Texas, 78209, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

QEII Health Sciences Centre/Capital District Health Authority

Halifax, Nova Scotia, B3H 1V8, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Department of Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

The Research Institute of the McGill University Health Centre (MUHC)

Montreal, Quebec, H3H 2R9, Canada

Location

Related Publications (3)

• Lerner SP, Tangen C, Svatek RS, Daneshmand S, Pohar KS, Skinner E, Schuckman A, Sagalowsky AI, Smith ND, Kamat AM, Kassouf W, Plets M, Bangs R, Koppie TM, Alva A, La Rosa FG, Pal SK, Kibel AS, Canter DJ, Thompson IM Jr; SWOG S1011 Trial Investigators. Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer. N Engl J Med. 2024 Oct 3;391(13):1206-1216. doi: 10.1056/NEJMoa2401497.

  PMID: 39589370 DERIVED

• 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.

  PMID: 27345655 DERIVED

• 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.

  PMID: 25150172 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: SWOG Statistician
• Organization: SWOG Statistics and Data Management Center

ctangen@fredhutch.org

2066674623

Study Officials

• Seth P. Lerner, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 20, 2010
• Study Start: November 25, 2011
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-11

Locations

US (29); CA (6)