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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

Phase 3
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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,

- 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


- 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.


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free progression

Safety Issue:


Principal Investigator

Seth P. Lerner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine



Study ID:




Start Date:

August 2011

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage II bladder cancer
  • stage III bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
University of California Davis Cancer Center Sacramento, California  95817
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Baylor University Medical Center - Houston Houston, Texas  77030-2399
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Knight Cancer Institute at Oregon Health and Science University Portland, Oregon  97239-3098
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Parkland Memorial Hospital Dallas, Texas  75235
Stanford Cancer Center Stanford, California  94305-5824
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital Houston, Texas  77030