Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
This study is currently recruiting participants.
Verified October 2012 by National Cancer Institute (NCI)
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01224665
First received: October 19, 2010
Last updated: November 1, 2012
Last verified: October 2012
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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 | Phase |
|---|---|---|
|
Bladder Cancer |
Procedure: therapeutic conventional surgery Procedure: therapeutic lymphadenectomy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Disease-free progression [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
- Morbidity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 620 |
| Study Start Date: | August 2011 |
| Estimated Primary Completion Date: | August 2022 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients undergo radical cystectomy and standard pelvic lymphadenectomy.
|
Procedure: therapeutic conventional surgery
Patients undergo radical cystectomy
Procedure: therapeutic lymphadenectomy
Patients undergo standard or extended pelvic lymphadenectomy.
|
|
Experimental: Arm II
Patients undergo radical cystectomy and extended pelvic lymphadenectomy.
|
Procedure: therapeutic conventional surgery
Patients undergo radical cystectomy
Procedure: therapeutic lymphadenectomy
Patients undergo standard or 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 and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224665
Locations
| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
| Los Angeles, California, United States, 90089-9181 | |
| Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
| Stanford Cancer Center | Recruiting |
| Stanford, California, United States, 94305-5824 | |
| Contact: Clinical Trials Office - Stanford Cancer Center 650-498-7061 cctoffice@stanford.edu | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Robert L. Grubb, III 314-747-7222 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Bernard H. Bochner 212-639-8895 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Jonathan W. Friedberg 585-275-5345 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 Jamesline@osumc.edu | |
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu | |
| United States, Texas | |
| Parkland Memorial Hospital | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Arthur I. Sagalowsky, MD 214-648-3976 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Seth P. Lerner, MD 713-798-6841 | |
| Baylor University Medical Center - Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Seth P. Lerner, MD 713-798-6841 | |
| University of Texas Health Science Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229-3900 | |
| Contact: Robert S. Svatek 210-567-4777 | |
Sponsors and Collaborators
Southwest Oncology Group
Investigators
| Principal Investigator: | Seth P. Lerner, MD | Baylor College of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT01224665 History of Changes |
| Other Study ID Numbers: | CDR0000686574, SWOG-S1011 |
| Study First Received: | October 19, 2010 |
| Last Updated: | November 1, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 May 19, 2013