Status:
COMPLETED
S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
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 e...
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 dissec...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 25 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
658 Patients enrolled
Trial Details
Trial ID
NCT01224665
Start Date
November 25 2011
End Date
May 1 2024
Last Update
November 29 2024
Active Locations (35)
Enter a location and click search to find clinical trials sorted by distance.
1
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
2
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
Stanford Cancer Institute
Palo Alto, California, United States, 94304
4
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817