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Brief Title: 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

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

INTRODUCTION

  • Org Study ID: S1011
  • Secondary ID: N/A
  • NCT ID: NCT01224665
  • Sponsor: SWOG Cancer Research Network

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.

  • Overall Status
    Active, not recruiting
  • Start Date
    November 25, 2011
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Seth P. Lerner, MD

Role: Principal Investigator

Affiliation: Baylor College of Medicine

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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