S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer - Full Text View

Purpose

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	Intervention
Bladder Cancer	Procedure: therapeutic conventional surgery Procedure: therapeutic standard lymphadenectomy Procedure: therapeutic extended lymphadenectomy


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking 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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer

Genetic and Rare Diseases Information Center resources: Transitional Cell Carcinoma

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

Disease-free survival [ Time Frame: Up to 6 years from date of Step 2 Registration ]

Secondary Outcome Measures:

Overall survival [ Time Frame: Up to 6 years from date of Step 2 Registration ]
Morbidity [ Time Frame: Up to 6 years from date of Step 2 Registration ]


Estimated Enrollment:	620
Study Start Date:	August 2011
Estimated Study Completion Date:	August 2022
Estimated Primary Completion Date:	August 2022 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 120 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224665

Contacts


Contact: Jennifer I Scott	210-614-8808 ext 1007	jscott@swog.org
Contact: Dana B Sparks, M.A.T.	210-614-8808 ext 1004	dsparks@swog.org

Show 35 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kamat AM, Hahn NM, Efstathiou JA, Lerner SP, Malmström 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. Review. Erratum in: Lancet. 2016 Dec 3;388(10061):2742.

Froehner M, Novotny V, Heberling U, Rutsch L, Litz RJ, Hübler 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.


Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT01224665 History of Changes
Other Study ID Numbers:	S1011 SWOG-S1011 ( Other Grant/Funding Number: U10CA180888 ) NCI-2011-02604 ( Registry Identifier: NCI )
Study First Received:	October 19, 2010
Last Updated:	April 20, 2017

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 Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site	Neoplasms Urinary Bladder Diseases Urologic Diseases

ClinicalTrials.gov processed this record on July 17, 2017